Clinical evidence on a unique two-step stannous fluoride dentifrice and whitening gel sequence.

PURPOSE: Recently, a unique two-step product was introduced that includes sequential use of a novel 0.454% stannous fluoride dentifrice followed by a 3% hydrogen peroxide whitening gel. The technology targeted advanced gingival health benefits plus esthetic benefits such as tooth whitening. The two-step sequence has unique brushing instructions to maximize the efficacy of each step; the stannous fluoride dentifrice is used for 1 minute of brushing followed by 1 minute of brushing with the hydrogen peroxide gel. This two-step sequence has been studied in numerous clinical trials over a series of years. This comprehensive program included different populations and sites, endpoints and time points, with responses measured versus different positive and negative research controls. A total of six clinical trials are reported herein. Outcomes from this research program demonstrate the significant gingival health efficacy of the two-step product, providing therapeutic efficacy comparable to chlorhexidine, and its positive impact on plaque, tooth stain and breath odor. CLINICAL SIGNIFICANCE: This unique dentifrice/gel sequence delivers a combination of advanced gingivitis efficacy with significant stain reduction - benefits that will positively impact oral health as well as patient compliance.

Safety and effectiveness of a two-step dentifrice/gel sequence with medication-associated hyposalivation: A randomized controlled trial in a vulnerable population.

PURPOSE: A randomized controlled trial was conducted to evaluate the safety and effectiveness of a two-step dentifrice/gel oral hygiene sequence in a vulnerable population. METHODS: Prior to the research, institutional review was obtained for the protocol, consent and advertising. The study targeted adults with medication-associated xerostomia, because of the plaque accumulation and possible oral safety risks seen in this population. Eligible subjects with a medication history and measured hyposalivation were randomly assigned to one of two oral hygiene groups:(1) a two-step 0.454% SnF2 dentifrice and 3% H2O2 gel sequence or (2) a regular anticavity toothpaste control. Test products were dispensed with a regular manual brush in blinded over-labeled kits with usage instructions. Subjects were evaluated at baseline and after 2 and 6 weeks of test product use. Safety was assessed as adverse events from clinical examination and interview. Digital plaque image analysis of the anterior facial teeth measured fluorescein-disclosed daytime plaque levels, and unstimulated saliva was collected over a 5-minute period in pre-weighed vials. RESULTS: A total of 49 subjects ranging from 31-80 years of age (53% female) were enrolled, and 45 completed Week 6. Only the two-step dentifrice and gel sequence differed significantly (P< 0.005) from baseline on daytime plaque coverage, and salivary flow increased significantly (P= 0.033) in that group as well. Between-group comparisons for daytime plaque favored the two-step sequence with 41-46% improvements in plaque control. At Week 6, adjusted daytime plaque means (SE) were 5.9 (0.7) and 10.0 (1.1) for the two-step and control groups, respectively (P< 0.004). Adverse events were mild in severity, groups differed significantly (P= 0.02) on occurrence, and events did not contribute to dropout. CLINICAL SIGNIFICANCE: In a randomized controlled trial among a vulnerable population, use of an oral hygiene sequence comprised of stannous fluoride dentifrice and a hydrogen peroxide whitening gel improved daily plaque control without adversely impacting salivary flow or oral health.

Randomized controlled trial evaluating concurrent gingivitis and stain effects of a two-step dentifrice/gel sequence.

PURPOSE: A randomized controlled trial was conducted to evaluate the clinical efficacy of a two-step dentifrice/whitening gel oral hygiene sequence on natural gingivitis and extrinsic stain. METHODS: The population consisted of healthy adults with clinical evidence of gingivitis and extrinsic stain. Consent, demographic information and clinical measurements were collected, after which subjects were randomized to treatment. Eligible subjects were dispensed blinded test kits containing over-labeled two-step 0.454% SnF2 dentifrice then 3% H2O2 whitening gel sequence or a regular 0.76% NaMFP dentifrice control (Colgate Cavity Protection), plus a regular soft manual toothbrush and instructions for use. Efficacy was assessed blind-to-treatment using the Gingivitis Bleeding Index (GBI) measured whole-mouth and the composite Lobene Stain Index (LSI) measured on the anterior dentition. Treatments were compared at Week 1 and Week 3 versus baseline for ΔGBI and ΔLSI using a two-sided 5% level of significance. RESULTS: A total of 61 subjects with a mean (SD) age of 33.4 (12.0) years were enrolled. Overall baseline means (SD) were 0.16 (0.05) for GBI and 1.30 (0.94) for LSI. After 1 week, only the two-step 0.454% SnF2 dentifrice then 3% H2 O2 whitening gel sequence demonstrated significant (P< 0.0001) reductions in both gingivitis and stain. Adjusted means for the changes with the dentifrice/gel sequence and control were -0.055 and -0.001 for ΔGBI, and -0.619 and -0.095 for ΔLSI, with groups differing significantly (P< 0.0001) on gingivitis and stain improvement. Outcomes at Week 3 were generally similar, with groups differing on bleeding and stain. Treatments were generally well-tolerated. CLINICAL SIGNIFICANCE: In a randomized controlled trial, use of a two-step 0.454% SnF2 dentifrice then 3% H2 O2 whitening gel sequence yielded concurrent improvements in gingivitis and stain compared to regular oral hygiene.

Initial evidence of two-step dentifrice/gel sequence effects on health: Outcomes from three randomized controlled trials.

PURPOSE: Health-related outcomes from three randomized controlled trials represented the initial research on the feasibility of novel, sequential oral hygiene with a stannous fluoride (SnF2) dentifrice then hydrogen peroxide (H2O2) whitening gel. METHODS: One crossover and two parallel clinical trials were conducted independently. Objectives varied, with individual studies assessing short, intermediate or longer-term outcomes from breath, dental plaque or gingivitis, respectively. Treatments were randomly assigned, and blinded test kits were dispensed containing either: 1) a two-step 0.454% SnF2 dentifrice and then a 3% H2O2 whitening gel sequence and instructions specifying 1+1 minute sequential brushing (experimental); or 2) 0.76% sodium monofluorophosphate dentifrice (Colgate Cavity Protection) and instructions for twice daily use (control). Standard methods were used to measure efficacy (volatile sulfur compounds, plaque area coverage or gingival bleeding) and safety (clinical examination and interview), and to compare treatment responses. RESULTS: Overall, 165 subjects participated in the three trials. Relative to baseline, only the experimental group exhibited significant (P< 0.05) improvements at initial and subsequent timepoints in each trial. Between-group comparisons showed significant (P< 0.05) 30-45% reductions in breath malodor (VSC), plaque (area%) and gingivitis (bleeding sites) favoring the experimental group. Adverse event occurrences were infrequent, mild in severity, and unrelated to dropout. CLINICAL SIGNIFICANCE: Important health-related outcomes from three initial clinical trials established the feasibility of sequential brushing with a two-step 0.454% SnF2 dentifrice and then a 3% H2O2 whitening gel.

Post-prophylaxis gingivitis prevention with two-step stannous fluoride dentifrice plus whitening gel sequence or chlorhexidine gluconate mouthrinse.

PURPOSE: To assess use of a two-step dentifrice/gel sequence versus chlorhexidine gluconate mouthrinse on gingivitis prevention after dental prophylaxis. METHODS: A 12-week, randomized controlled trial was conducted to compare the effectiveness and safety of a two-step dentifrice/gel sequence to a positive control in healthy adults with established gingivitis. After informed consent, gingivitis and stain levels were assessed by clinical examination. Eligible subjects received a dental prophylaxis and were randomly assigned to twice daily unsupervised use of either (1) two-step oral hygiene sequence:0.454% stannous fluoride dentifrice followed by 3.0% hydrogen peroxide whitening gel for the test group; or (2) 0.12% chlorhexidine gluconate oral rinse and 0.76% sodium monofluorophosphate dentifrice for the control group. Clinical measurements of gingivitis bleeding sites and tooth stain area/intensity were collected after 4, 8 and 12 weeks use, while safety was assessed via clinical examination and oral status interview of the subjects. RESULTS: A total of 44 subjects were enrolled and 35 completed the 12-week study. At baseline, bleeding sites ranged from 10-33. After prophylaxis and assigned treatment, both groups exhibited significant (P≤ 0.0001) reductions in bleeding sites. Responses were directionally better in the two-step sequence at all post-baseline timepoints, with groups differing significantly (P < 0.05) at Week 8. Tooth stain measurements demonstrated that the two-step dentifrice/gel sequence did not contribute to any significant (P> 0.13) stain accumulation. In contrast, stain accumulation was evident (P< 0.003) in the chlorhexidine group beginning at the Week 4 visit. Adverse events were more common in the positive control, and contributed to early termination. CLINICAL SIGNIFICANCE: Twice daily use of a two-step stannous fluoride dentifrice and peroxide whitening gel sequence after prophylaxis provided comparable or superior gingivitis benefits to chlorhexidine gluconate rinse without the concomitant side effect of staining.

A Randomized Controlled Clinical Trial to Evaluate the Efficacy of an Oscillating-Rotating Electric Toothbrush, a Stannous Fluoride Dentifrice, and Floss on Gingivitis.

OBJECTIVES: To evaluate the gingival health efficacy of an oscillating-rotating electric toothbrush, a stannous fluoride dentifrice, and dental floss in adults with mild-to-moderate gingivitis. METHODS: This was a single-center, randomized, controlled, examiner-blind, two-treatment, eight-week parallel group study in adults with at least 20 gingival bleeding sites. Eligible subjects were randomized equally to one of two groups: experimental oral hygiene group that included an Oral-B® oscillating-rotating electric toothbrush with round brush head (D20/EB20), Crest® stabilized stannous fluoride dentifrice (SnF2 1100 ppm F, NaF 350 ppm F), and Oral-B® Glide® floss; or regular oral hygiene control group that included a regular manual toothbrush (Oral-B® Indicator 35) and Crest® anti-cavity sodium fluoride dentifrice (NaF 1450 ppm F). Subjects followed manufacturer's instructions and used their assigned products over an eight-week period. Gingival health was measured at baseline, Week 4, and Week 8 using three assessments: Gingival Bleeding Index (GBI), number of bleeding sites, and Modified Gingival Index (MGI). Analysis of Covariance was used to compare gingival health between treatment groups. RESULTS: One hundred and twenty subjects, mean age 44 years (range: 21 to 74 years), were assessed at baseline (60 per group); 113 subjects (57 in control group, 56 in experimental group) completed the study with fully evaluable data. At baseline, the groups were balanced; overall means were 0.41 for GBI, 51.7 for bleeding sites, and 1.44 for MGI. Only the experimental group showed statistically significant reductions from baseline (p < 0.0001) for all three gingivitis assessments at both Weeks 4 and 8. At these time points, better gingival health for the experimental group was seen as significantly lower adjusted mean scores versus the control group (p < 0.0001) for all three assessments. Reductions in favor of the experimental group at Weeks 4 and 8, respectively, were 51% and 45% for GBI, 46% and 40% for number of bleeding sites, and 37% and 20% for MGI. The study treatments were well tolerated. CONCLUSIONS: Over an eight-week period, an oral hygiene routine with an oscillating-rotating electric toothbrush, stannous fluoride dentifrice, and floss significantly improved gingivitis compared to regular hygiene with a manual toothbrush and an anti-cavity sodium fluoride dentifrice.

Placebo-controlled clinical trial evaluating 9.5% hydrogen peroxide high-adhesion whitening strips.

OBJECTIVE: To evaluate the effectiveness and tolerability of an experimental 9.5% hydrogen peroxide whitening strip relative to a placebo control over a three-week period. METHODS: In this parallel-design, double-blind clinical trial, 54 adult volunteers were randomized to an experimental 9.5% hydrogen peroxide whitening strip or placebo strip balancing for age and baseline tooth color, and received treatment. Strips were worn on the maxillary arch 30 minutes daily for 20 days. Efficacy was measured objectively as L*a*b* color change from digital images at Days 4, 7, 15, and 21. RESULTS: As early as Day 4 and at all subsequent visits, the 9.5% strip group experienced significant (p < 0.004) color improvement relative to placebo for b* and L* color parameters. The amount of color improvement increased with continuing peroxide strip use. Mean ± SE between-group differences in Ab* were -0.6 ± 0.16, -0.8 ± 0.15, -1.6 ± 0.19, and -1.9 ± 0.20 at Days 4, 7, 15, and 21, respectively. Similar results were noted for AL*. Minor tooth sensitivity was the most common adverse event, as reported by 12% of subjects in the 9.5% strip group and 11% of subjects in the placebo group. No subjects discontinued treatment due to an adverse event. CONCLUSION: This placebo-controlled clinical trial demonstrated that an experimental 9.5% hydrogen peroxide strip yielded significant tooth whitening relative to a placebo strip as early as after three days of product use.

Evaluation of an advanced oral hygiene regimen on maternity outcomes in a randomized multicenter clinical trial (Oral Hygiene and Maternity Outcomes Multicenter Study).

BACKGROUND: During pregnancy, dental plaque-induced gingivitis prevalence and subsequent risk of periodontal disease increases substantially, as a consequence of both inadequate oral hygiene and changes in sex steroid hormone levels. Although maternal periodontal disease has been associated with adverse pregnancy outcomes, including spontaneous preterm birth, previous clinical trials involving mechanical debridement (eg, scaling and root planing) to remove plaque biofilm have not yielded decreased rates of preterm birth. OBJECTIVE: We hypothesized that an advanced oral hygiene program, including an antibacterial regimen coupled with a power toothbrush and hygiene instruction, may improve the periodontal milieu and reduce the rate of spontaneous preterm birth. Therefore, we conducted a clinical trial of obstetrical patients with moderate-to-severe gingivitis who were randomized to an advanced oral hygiene program vs usual oral hygiene care, and the primary obstetrical outcome compared between the treatment groups was gestational age at delivery. STUDY DESIGN: Obstetrical patients with singleton pregnancies between 8 and 24 weeks' gestation were screened by trained dentists at 2 clinical sites for moderate-to-severe gingivitis (>30 intraoral sites with gingival bleeding on probing). Eligible participants were randomized to an advanced oral hygiene regimen, including antibacterial mouth wash, dental floss, antibacterial toothpaste, a power toothbrush, and intensive oral hygiene education vs standard oral home care instructions and regimen. The primary obstetrical outcome assessed was gestational age at delivery. The overall primary (dental) outcomes were gingival index, bleeding sites, and pocket depth (reported elsewhere). Secondary obstetrical outcomes included birthweight and incidence of preterm birth at <37 weeks' gestation. Regression models were utilized and included factors such as treatment group, gestational age at enrollment, preterm birth history, and potential markers of health disparities (ie, education, employment status). RESULTS: A total of 817 obstetrical patients underwent dental screening at the 2 sites, 789 were identified with moderate-to-severe gingivitis, 746 were randomized, and birth outcomes were available for 613 of the study participants. The gestational age at delivery was 2 days earlier in the control group (P=.040), but the clinical significance of this finding was limited (39.13 vs 38.85 weeks). Overall rates of spontaneous preterm birth <37 weeks and <34 weeks were not statistically different between the 2 treatment groups (7.0% advanced oral hygiene regimen vs 10.3% controls, OR=1.63 (0.90-3.00), P=.11; and 2.3% vs 3.9%, OR=1.88 (0.71-4.98), P=.20, respectively). However, we observed lower rates of spontaneous preterm birth among unemployed participants with less favorable socioeconomic status (4.7% advanced oral hygiene regimen vs 16.0% controls, OR=4.04 (1.34-15.12), P=.01). CONCLUSION: An advanced oral hygiene program may reduce the risk of spontaneous preterm birth among pregnant patients with moderate-to-severe gingivitis and health disparities. This is the same group that may be at highest risk of poor dental hygiene and preterm birth.

A Randomized Controlled Clinical Trial of Prenatal Oral Hygiene Education in Pregnancy-Associated Gingivitis.

INTRODUCTION: Research shows there is a significant increase in gingival inflammation during pregnancy. This study was conducted to determine if an oral health intervention (OHI), including oral hygiene education delivered by nurse-led staff and an advanced over-the-counter (OTC) oral home care regimen, improved gingival inflammation in pregnant women with moderate-to-severe gingivitis compared with a standard oral hygiene control group. METHODS: This was a multicenter, randomized, controlled, single-masked, parallel group clinical trial conducted in obstetrics clinics of 2 medical centers. A total of 750 pregnant women between 8 and 24 weeks of pregnancy with at least 20 natural teeth and moderate-to-severe gingivitis (>30 intraoral bleeding sites) were enrolled. Participants were randomized to either the OHI group, which included oral hygiene instructions supplemented with an educational video and advanced OTC antibacterial/mechanical oral hygiene products, or the control group receiving oral hygiene instructions and standard products. Both groups received oral hygiene instructions from nurse-led staff. Experienced, masked examiners measured whole mouth gingival index (GI) and periodontal probing depths (PDs) at baseline and months 1, 2, and 3. RESULTS: Participants enrolled in this study presented with moderate-to-severe gingivitis at baseline. Both the OHI and control groups exhibited significant reductions in GI (P < .001) and PD (P < .03) from baseline that persisted throughout the study period. The OHI group exhibited modest, yet statistically greater, reductions in GI (P ≤ .044) compared with the control at all time points. The reduction in PD directionally favored the OHI group, but between-group differences were small (<0.03 mm) and not statistically significant (P > .18). DISCUSSION: Significant gingivitis was prevalent among participants in this study and identifies an opportunity to improve gingival health during pregnancy by providing oral health education during the course of prenatal care when coupled with an advanced OTC oral hygiene regimen.

Parameters for pyrethroid insecticide QSAR and PBPK/PD models for human risk assessment.

In this review we have examined the status of parameters required by pyrethroid QSAR-PBPK/PD models for assessing health risks. In lieu of the chemical,biological, biochemical, and toxicological information developed on the pyrethroids since 1968, the finding of suitable parameters for QSAR and PBPK/PD model development was a monumental task. The most useful information obtained came from rat toxicokinetic studies (i.e., absorption, distribution, and excretion), metabolism studies with 14C-cyclopropane- and alcohol-labeled pyrethroids, the use of known chiral isomers in the metabolism studies and their relation to commercial products. In this review we identify the individual chiralisomers that have been used in published studies and the chiral HPLC columns available for separating them. Chiral HPLC columns are necessary for isomer identification and for developing kinetic values (Vm,, and Kin) for pyrethroid hydroxylation. Early investigators synthesized analytical standards for key pyrethroid metabolites, and these were used to confirm the identity of urinary etabolites, by using TLC. These analytical standards no longer exist, and muste resynthesized if further studies on the kinetics of the metabolism of pyrethroids are to be undertaken.In an attempt to circumvent the availability of analytical standards, several CYP450 studies were carried out using the substrate depletion method. This approach does not provide information on the products formed downstream, and may be of limited use in developing human environmental exposure PBPK/PD models that require extensive urinary metabolite data. Hydrolytic standards (i.e., alcohols and acids) were available to investigators who studied the carboxylesterase-catalyzed hydrolysis of several pyrethroid insecticides. The data generated in these studies are suitable for use in developing human exposure PBPK/PD models.Tissue:blood partition coefficients were developed for the parent pyrethroids and their metabolites, by using a published mechanistic model introduced by Poulin and Thiele (2002a; b) and log DpH 7.4 values. The estimated coefficients, especially those of adipose tissue, were too high and had to be corrected by using a procedure in which the proportion of parent or metabolite residues that are unbound to plasma albumin is considered, as described in the GastroPlus model (Simulations Plus, Inc.,Lancaster, CA). The literature suggested that Km values be adjusted by multiplying Km by the substrate (decimal amount) that is unbound to microsomal or CYPprotein. Mirfazaelian et al. (2006) used flow- and diffusion-limited compartments in their deltamethrin model. The addition of permeability areas (PA) having diffusion limits, such as the fat and slowly perfused compartments, enabled the investigators to bring model predictions in line with in vivo data.There appears to be large differences in the manner and rate of absorption of the pyrethroids from the gastrointestinal tract, implying that GI advanced compartmental transit models (ACAT) need to be included in PBPK models. This is especially true of the absorption of an oral dose of tefluthrin in male rats, in which 3.0-6.9%,41.3-46.3%, and 5.2-15.5% of the dose is eliminated in urine, feces, and bile,respectively (0-48 h after administration). Several percutaneous studies with the pyrethroids strongly support the belief that these insecticides are not readily absorbed, but remain on the surface of the skin until they are washed off. In one articular study (Sidon et al. 1988) the high levels of permethrin absorption through the forehead skin (24-28%) of the monkey was reported over a 7- to 14-days period.Wester et al. (1994) reported an absorption of 1.9% of pyrethrin that had been applied to the forearm of human volunteers over a 7-days period.SAR models capable of predicting the binding of the pyrethroids to plasma and hepatic proteins were developed by Yamazaki and Kanaoka (2004), Saiakhov et al. (2000), Colmenarejo et al. (2001), and Colmenarejo (2003). QikProp(Schrodinger, LLC) was used to obtain Fu values for calculating partition coefficients and for calculating permeation constants (Caco-2, MDCK, and logBBB). ADMET Predictor (Simulations Plus Inc.) provided Vm~,x and Km values for the hydroxylation of drugs/pyrethroids by human liver recombinant cytochrome P450 enzymes making the values available for possible use in PBPK/PD models.The Caco-2 permeability constants and CYP3A4 Vmax and Km values are needed in PBPK/PD models with GI ACAT sub models. Modeling work by Chang et al.(2009) produced rate constants (kcat) for the hydrolysis of pyrethroids by rat serumcarboxylesterases. The skin permeation model of Potts and Guy (1992) was used topredict K, values for the dermal absorption of the 15 pyrethroids.The electrophysiological studies by Narahashi (1971) and others (Breckenridgeet al. 2009; Shafer et al. 2005; Soderlund et al. 2002; Wolansky and Harrill 2008)demonstrated that the mode of action of pyrethroids on nerves is to interfere with the changes in sodium and potassium ion currents. The pyrethroids, being highly lipid soluble, are bound or distributed in lipid bilayers of the nerve cell membrane and exert their action on sodium channel proteins. The rising phase of the action potential is caused by sodium influx (sodium activation), while the falling phase is caused by sodium activation being turned off, and an increase in potassium efflux(potassium activation). The action of allethrin and other pyrethroids is caused by an inhibition or block of the normal currents. An equation by Tatebayashi and Narahashi (1994) that describes the action of pyrethroids on sodium channels was found in the literature. This equation, or some variation of it, may be suitable for use in the PD portion of pyrethroid PBPK models.

Randomized controlled trial of 0.454% stannous fluoride dentifrice to treat gingival bleeding.

PURPOSE: To evaluate the effects of a highly bioavailable 0.454% stannous fluoride dentifrice on established gingival bleeding over a 3-month period. MATERIALS AND METHODS: A randomized controlled clinical trial was conducted. In total, 100 adults with mild-to-moderate gingivitis and an average of 15 bleeding sites were assigned to either the stannous fluoride or regular control pastes for at-home use. Of these, 99 received study treatment and 97 completed the study. RESULTS: The stannous fluoride group experienced 50% to 74% reductions in bleeding sites relative to baseline or the control, differing significantly (P < 0.001) at all time points. Most subjects in the stannous fluoride group (94%) had measured improvements in bleeding, and nearly one half completed treatment with one or no bleeding sites. CONCLUSION: These study results suggest that incorporation of this 0.454% stannous fluoride dentifrice into daily oral hygiene maybe expected to yield less gingival bleeding at subsequent dental check-ups, and therefore reduce the risk of progressive periodontal disease.

Use of alcohol-free antimicrobial mouth rinse is associated with decreased incidence of preterm birth in a high-risk population.

OBJECTIVE: We sought to determine if treatment of periodontal disease during pregnancy with an alcohol-free antimicrobial mouth rinse containing cetylpyridinium chloride impacts the incidence of preterm birth (PTB) in a high-risk population. STUDY DESIGN: This single-blind clinical trial studied pregnant women (6-20 weeks' gestation) with periodontal disease who refused dental care. Subjects receiving mouth rinse were compared to designated controls who did not receive rinse (1 rinse:2 controls), balanced on prior PTB and smoking. Primary outcome was PTB <35 weeks. RESULTS: In all, 226 women were included in the analysis (71 mouth rinse subjects, 155 controls). Incidence of PTB <35 weeks was lower in the rinse group compared to controls (5.6% and 21.9% respectively, P < .01); relative risk was 0.26 (95% confidence interval, 0.096-0.70). Gestational age and birthweight were significantly higher in the rinse group (P < .01). CONCLUSION: A nonalcohol antimicrobial mouth rinse containing cetylpyridinium chloride was associated with decreased incidence of PTB <35 weeks.

Long-term use of 6.5% hydrogen peroxide bleaching strips on tetracycline stain: a clinical study.

UNLABELLED: This study evaluated the clinical response following extended daily use of a trayless 6.5% hydrogen peroxide (H2O2) tooth bleaching gel in patients with tetracycline stains. MATERIALS AND METHODS: In this clinical trial, participants (N = 30) were assigned to a strip product following screening for tetracycline staining. Subjects used the product for 6 months, with clinical safety and efficacy measurements assessed at the end of each month. The strips were used for 30 minutes twice daily (maxillary arch only). Treatment efficacy was determined by the tooth color change from baseline using an expanded VITA shade guide. Additional shades were added on either side, representing colors whiter than B1 and darker than C4. RESULTS: The strips averaged shade reduction in Months 1, 2, and 3 visits, respectively. Of all the subjects, 65% reached B1 color by Month 6. Treatment was generally well tolerated. Mild and transient tooth sensitivity (46.7%) and oral discomfort (43.3%) were the most common adverse events associated with daily bleaching, yet neither affected study participation. CONCLUSIONS: The 6.5% H2O2 bleaching strip provided significant tooth whitening in subjects with tetracycline stains. CLINICAL SIGNIFICANCE: When used daily for 6 months, a 6.5% H2O2 bleaching strip can be effective in whitening tetracycline stains. The professional strip was well tolerated throughout the 6-month period. This extended use provides additional evidence of clinical safety associated with the use of this product for vital bleaching.

Effects of an oral hygiene regimen on progression of gingivitis/early periodontitis: A randomized controlled trial.

Background: Periodontal disease continues to be prevalent globally, but little clinical research has been undertaken to evaluate the long-term benefits of a daily oral hygiene regimen on progression of gingivitis/early periodontitis. The objective of this study was to evaluate the effects of an oral hygiene regimen (OHR) on the periodontal health of adults in good general health with established gingivitis and early periodontitis over 24 months. Methods: A randomized controlled trial was conducted in adults with established gingivitis, with isolated sites of probing pocket depth >4 mm. Study participants were randomized to the OHR (bioavailable stannous fluoride dentifrice, oscillating-rotating electric toothbrush, cetylpyridinium chloride rinse, and floss; P&G) or usual care products (sodium fluoride dentifrice and manual toothbrush; P&G) groups. At baseline and every 6 months, gingivitis and periodontal measures were assessed and a prophylaxis was conducted. The primary outcome was Gingival Bleeding Index-Bleeding Sites (GBI-BS). Analyses used ANCOVA at 5% significance levels. Results: A total of 107 individuals were enrolled; 87 completed the study. Mean GBI-BS, Modified Gingival Index, and Probing Pocket Depth (PPD) scores were significantly lower at each visit for the OHR versus usual care group by 28% to 39%, 12% to 18%, and 6% to 13%, respectively (p≤ 0.0009). The magnitude of reduction in median number of ≥2 mm PPD loss events for OHR versus the usual care group at 24 months was 74%. Conclusion: Long-term use of the OHR produced significant periodontal health improvements versus the usual care products.

Contexte: La maladie parodontale continue d'être prévalente sur le plan mondial, mais peu de recherches cliniques ont été effectuées pour évaluer les avantages à long terme d'un régime d'hygiène buccodentaire sur la progression de la gingivite ou de la parodontite précoce. L'objectif de cette étude était d'évaluer les effets d'un régime d'hygiène buccodentaire (RHB) sur la santé parodontale des adultes en bonne santé générale qui présentent une gingivite établie et une parodontite précoce au cours de 24 mois. Méthodologie: Un essai contrôlé randomisé a été effectué chez des adultes présentant une gingivite établie et des sites isolés de profondeurs de poches au sondage >4 mm. Les participants de l'étude ont été confiés à un groupe de RHB aléatoire (pâte dentifrice au fluorure stanneux biodisponible, une brosse à dents électrique rotative et oscillante, un rince-bouche au chlorure de cétylpyridinium et la soie dentaire; P & G) ou à un groupe de produits de soins habituels (dentifrice au fluorure de sodium et une brosse à dents manuelle; P & G). La gingivite et les mesures parodontales ont été évaluées au début de l'intervention et tous les 6 mois et une prophylaxie avait été effectuée. Le résultat primaire était l'Indice de saignement gingival­les sites de saignements (ISG­SS). L'analyse de covariance a été utilisée à des seuils de signification de 5 %. Résultats: Un total de 107 personnes ont été inscrites : 87 ont terminé l'étude. Les cotes moyennes de l'ISG­SS, de l'indice gingival modifié et des cotes de profondeurs des poches au sondage (PPS) étaient significativement plus faibles à chaque visite du groupe de RHB par rapport au groupe de soins habituels, de 28 % à 39 %, 12 % à 18 % et 6 % à 13 %, respectivement (p≤ 0,0009). L'ampleur de la réduction en nombre médian d'événements de perte de PPS ≥2 mm du groupe de RHB par rapport au groupe de soins habituels était de 74 % à 24 mois. Conclusion: L'utilisation à long terme du RHB a produit des améliorations significatives de la santé parodontale par rapport aux produits de soins habituels.

Clinical trials, case studies, and oral care R&D: inclusivity, consistency, and other atypical evidence.

Evidence-based assessment plays an obvious, growing, and critical role in directly informing clinical decisions in dentistry. The inputs are complex from diverse sources, and outcomes can appreciably influence the research and development process. Emerging trends may indicate the need for assessment of even more complex data. As exemplified by whitening strips development, inclusive, consistent, and atypical evidence may be considered for informed decision making. In addition to the direct applications, such assessment may indirectly support decision making by professional associations, government authorities, and other health care organizations that influence clinical practice behaviors.

Placebo-controlled clinical trial of use of 10% hydrogen peroxide whitening strips for medication-induced xerostomia.

OBJECTIVE: A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effectiveness and safety of peroxide-containing strip-based tooth whitening among subjects with medication-induced hyposalivation. METHODS: Eligibility for this tooth whitening study was limited to dentate adults taking xerogenic medications with an unstimulated salivary flow < or = 0.2 ml/min. After giving informed consent, 42 subjects were randomized using a 2:1 ratio to 10% hydrogen peroxide whitening strips (Crest Whitestrips Premium) or placebo strips without peroxide. Strips were used for 30 min twice daily for a 14-day period. Usage was unsupervised, and only the maxillary arch was treated. On days 8 and 15, efficacy was assessed from standard digital images of the anterior dentition and quantified using the Cielab color system, while safety was assessed from interviews and clinical examinations. RESULTS: At day 8, the peroxide group experienced significant (p < 0.001) color improvement relative to baseline and placebo. Adjusted means +/- standard errors for yellowness reduction were -1.65 +/- 0.115 units for the peroxide group and -0.32 +/- 0.170 units for the placebo group. For the increase in lightness, adjusted means +/- standard errors on day 8 were 1.53 +/- 0.130 units for the peroxide group and 0.37 +/- 0.191 units for the controls. Continued strip use through day 15 yielded incremental color improvement for the peroxide group. Mild and transient tooth sensitivity represented the most common adverse events. No subject discontinued treatment due to a product-related adverse event. CONCLUSION: Twice daily use of 10% hydrogen peroxide whitening strips by adults with medication-induced xerostomia was well tolerated, with significant tooth color improvement evident within 7 days.

Clinical trial assessing light enhancement of in-office tooth whitening.

OBJECTIVE: Evaluate a light-enhanced in-office tooth whitening system in order to assess tooth color and safety. METHODS: Thirty-three adults were randomly assigned to one of three treatment groups. Professional treatment involved application of a 25% H(2)O(2) gel (Discus Dental ZOOM!) with light enhancement, H(2)O(2) gel alone, or the light alone with no peroxide. The 12 anterior teeth were treated three times for 20 minutes each. Efficacy was measured objectively as L*a*b* color change using digital images, tooth shade was measured, and safety was evaluated immediately after treatment and at posttreatment days 7 and 30. RESULTS: After adjusting for baseline and age, immediate (end-of-treatment) means (SE) for Deltab* (yellowness) were -3.1 (0.25) for the gel + light, -2.0 (0.25) for the gel-only group, and -2.4 (0.25) for the light-only group. Significant (p < 0.05) color rebound was evident at posttreatment day 7. By day 30, adjusted means (SE)for Deltab* were -1.7 (0.20) for the gel + light group, -1.1 (0.20) for the gel-only group, and -0.5 (0.20) for the light-only group. Both peroxide groups differed significantly (p < 0.05) from light alone on Deltab* and DeltaL*. In the gel + light group, 91% of subjects experienced tooth sensitivity, the majority of which was moderate or severe. Adverse events were low in the light-only group. CONCLUSION: Use of light enhancement for in-office whitening leads to immediate color change, after which there was significant color and shade rebound within 7 days as well as moderate-to-severe tooth sensitivity during and after treatment. CLINICAL SIGNIFICANCE Increased tooth sensitivity during treatment and appreciable short-term color rebound after treatment may impact the utility of in-office tooth whitening with peroxide and light as a stand-alone esthetic procedure. (J Esthet Restor Dent 21:336-347, 2009).

In-use peroxide kinetics of 10% hydrogen peroxide whitening strips.

OBJECTIVE: Clinical research was conducted to establish the peroxide degradation profile of a very thin 10% hydrogen peroxide bleaching gel delivered on a flexible polyethylene strip. METHODS: Sixteen subjects participated in this study of Crest Whitestrips Premium, a thin layer of 10% hydrogen peroxide gel. Application was supervised, and strips were removed after five, 10, 30, and 60 minutes. Samples were collected from the strips, teeth, gingiva, and saliva, and peroxide levels were derived using a colorimetric peroxide assay. RESULTS: At five minutes, median peroxide concentrations were 7.3%, 6.4%, and 0.7% for strips, teeth, and gingiva, respectively, declining to 4.6%, 2.9%, and 0.1% at 30 minutes. Salivary samples never exceeded a median concentration of 0.014% at any time point. Samples differed significantly (p < 0.01) with respect to the 30- and 60-minute area-under-the-curve calculations, with the highest concentrations on the strip and teeth, and the lowest on the gingiva and in saliva. Median peroxide concentrations on strips and teeth remained above 2% over 60 minutes. At all post-treatment time points, the gingival peroxide concentration was an order of magnitude lower than the teeth samples. CONCLUSION: Use of 10% hydrogen peroxide whitening strips yielded appreciable peroxide on teeth over a 60-minute period, with rapid peroxide degradation on the gingiva, and exceedingly low accumulation in saliva anytime during use.

Short-term effects of a combination product night-time therapeutic regimen on breath malodor.

AIM: To evaluate the malodor reduction benefits of a therapeutic night-time oral hygiene regimen that combined antibacterial toothpaste and mouthrinse with an oscillating-rotating rechargeable power toothbrush. METHODS AND MATERIALS: An independent clinical trial was conducted using a randomized, negative-controlled, single blind, two treatment, 4-period crossover design. After completing a 1-week acclimation period, subjects were randomly assigned to a treatment sequence consisting of the following two regimens: (1) a night-time regimen of Crest Pro-Health Night dentifrice, Crest Pro-Health Night rinse, and Oral-B Vitality Precision Clean power toothbrush and (2) a control regimen of Crest Cavity Protection dentifrice and an ADA manual toothbrush. Each treatment period started with an overnight baseline volatile sulfur compounds (VSCs) Halimeter measurement, followed by twice daily use of the assigned regimen. Post-treatment overnight malodor was assessed at 24 hours. There were 2-day washout periods between treatments. All procedures were repeated with the next assigned regimen, through four crossover periods. RESULTS: Twenty-five subjects completed the study. Twice daily use of the therapeutic night-time regimen resulted in a significant (p>0.001) 35% reduction of mean VSC levels in the overnight breath compared to the control regimen. CONCLUSION: One-day use of a night-time regimen consisting of a therapeutic paste, rinse, and an oscillating-rotating rechargeable power toothbrush provided a 35% reduction in overnight breath malodor compared to regular brushing. CLINICAL SIGNIFICANCE: Combining a proven therapeutic dentifrice, mouthrinse, and advanced design toothbrush in a single regimen is an efficient means of maximizing breath odor reductions.

A Comparison of Oral Hygiene Products and Professional Care: A six-week randomized clinical trial.

Purpose: To investigate the anti-gingivitis efficacy of a novel oral hygiene routine consisting of a two-step stannous fluoride dentifrice and hydrogen peroxide whitening gel system, an interactive oscillating-rotating electric toothbrush, and expanded polytetrafluoroethylene floss.Methods: A total of 52 participants (n=52;mean age 35.8±11.23 years) were enrolled in the study and randomized 1:1 to the experimental hygiene group or control (dental prophylaxis followed by use of standard sodium fluoride dentifrice and a manual toothbrush). Participants were instructed to brush twice daily; those in the experimental group were instructed to floss once daily. Oral examinations were conducted at Baseline, Week 2, Week 4, and Week 6.Results: Both groups experienced significant declines in the mean number of bleeding sites from Baseline at all time points, evident as early as Week 2. Bleeding sites continued to decline throughout the trial in the experimental group, whereas they showed an increasing trend between Weeks 2 and 6 in the control group. The experimental group had 55% fewer bleeding sites at Week 2, 85% fewer bleeding sites at Week 4, and 98% fewer bleeding sites at Week 6 (p<0.0001 for all) as compared to the control group. At Week 6, 84% of participants in the experimental group had no bleeding, while all participants in the control group had bleeding.Conclusion: The experimental oral hygiene group showed significantly greater reductions in gingival bleeding than the control oral hygiene group, with benefits seen as early as Week 2 and increasing over the six-week study.