A fluoride dose-response evaluation in an anticaries clinical trial.

This study evaluated the dose-response relationship between four increasing levels of fluoride from 1000 to 2500 ppm F as sodium monofluorophosphate (MFP) and three-year dental caries increments, as measured by DMFS, DMFT, and DFS-A on 4424 schoolchildren. The results indicated consistent linear decreases in all three dental indices as the dose level increased to 2500 ppm F MFP, with slopes (average reductions) of 0.32 in DMFS for an increase of 1000 ppm F, 0.13 in DMFT, and 0.17 in DFS-A when all children were evaluated, p less than 0.03 for each index. For children 11 years and older at baseline, the slopes quadrupled, p less than 0.01 for each index. Age and baseline DMFS were shown to be the most important covariates to control for in the statistical models. No differences in adverse reactions, or other safety problems, were observed at the different dose levels.

Influence of a chlorhexidine and a zinc mouthrinse on gingivitis.

The end point methodology did not indicate a difference between the agents. The prophylaxis effect was only demonstrable through 8 weeks, although the analysis of variance indicated a prophylaxis effect on gingival index throughout the study. An agent effect was not demonstrable in the study. The "positive control," chlorhexidine, did not give the same results in this brushing study as in previous no-brushing studies reported by Loe and by our group. One might conclude that the effectiveness of brushing in reducing gingivitis is greater than the effect of chlorhexidine. Decreasing plaque and gingivitis scores are seen with increasing time, probably reflecting increased subject interest and involvement in the study. Mere involvement in the study apparently produced a beneficial effect on gingival health. This "placebo effect" also has been noted in an earlier study. A similar decrease in plaque scores in a placebo group attributable to a general improvement of oral hygiene was reported by Gjermo and Rolla. The subjects who began the study with no calculus (prophylaxis group) had consistently lower calculus scores than those not given a prophylaxis. This difference became less distinct at later exams, as the treated group developed calculus. The agents, although ineffective under the test regimen produced no adverse effects.

Clinical evaluation of a newly designed contoured tooth-brush.

A newly designed contoured toothbrush was tested against the Oral B toothbrush in a single blind crossover study over a 6-month period using 78 patients. The findings were: (1) The contoured toothbrush was significantly better (P less than 0.01) than the Oral B brush for gingival index scores; (2) Plaque scores were lower for the contoured brush (P = 0.10); (3) No significant differences were observed with respect to calculus scores.

Hydrogen peroxide: a review of its use in dentistry.

Several dentifrices that contain hydrogen peroxide are currently being marketed. The increased use of bleaching agents containing (or generating) H2O2 prompted this review of the safety of H2O2 when used in oral hygiene. Daily exposure to the low levels of H2O2 present in dentifrices is much lower than that of bleaching agents that contain or produce high levels of H2O2 for an extended period of time. Hydrogen peroxide has been used in dentistry alone or in combination with salts for over 70 years. Studies in which 3% H2O2 or less were used daily for up to 6 years showed occasional transitory irritant effects only in a small number of subjects with preexisting ulceration, or when high levels of salt solutions were concurrently administered. In contrast, bleaching agents that employ or generate high levels of H2O2 or organic peroxides can produce localized oral toxicity following sustained exposure if mishandled. Potential health concerns related to prolonged hydrogen peroxide use have been raised, based on animal studies. From a single study using the hamster cheek pouch model, 30% H2O2 was referred to as a cocarcinogen in the oral mucosa. This (and later) studies have shown that at 3% or less, no cocarcinogenic activity or adverse effects were observed in the hamster cheek pouch following lengthy exposure to H2O2. In patients, prolonged use of hydrogen peroxide decreased plaque and gingivitis indices. However, therapeutic delivery of H2O2 to prevent periodontal disease required mechanical access to subgingival pockets. Furthermore, wound healing following gingival surgery was enhanced due to the antimicrobial effects of topically administered hydrogen peroxide. For most subjects, beneficial effects were seen with H2O2 levels above 1%.

A 3-year clinical trial to compare efficacy of dentifrices containing 1.14% and 0.76% sodium monofluorophosphate.

A 3-yr daily supervised toothbrushing study with a double blind design was conducted to evaluate the anticaries effectiveness of a 1.14% sodium monofluorophosphate (MFP) dentifrice (1500 ppm F) compared to a 0.76% MFP dentifrice (1000 ppm F). This study began with nearly 4000 children, primarily aged 8-11, in grades 3-5, residing in a nonfluoridated community in Florida. A total of 2415 children completed 3 yr of the study, representing 61% of the children who began the study. The results indicate a statistically significant (P less than 0.001) anticaries benefit was derived over a 3-yr period from the use of the higher fluoride dentifrice (1500 ppm F) when compared to the positive control (1000 ppm F). Percent reductions in mean dental caries increments were 20.9%, 22.1%, 21.8%, 24.3%, and 35.2% for DMFT, DFT, DMFS, DFS, and DFS Interproximal, respectively.

Anticalculus effect of a dentifrice containing 0.5% zinc citrate trihydrate.

A doubleblind 3-month anticalculus clinical study was conducted to determine the magnitude of the antitartar effect to be derived from use of a 0.5% zinc citrate dentifrice. From a population of 1600 subjects exhibiting calculus, 1210 subjects (age 18 and over) were selected and received a dental prophylaxis. The subjects were initially stratified on the basis of calculus score, age, and sex, then allocated randomly to a 3-month usage period of one of two treatment groups. These were a dentifrice containing 0.5% zinc citrate or a control dentifrice without zinc citrate. Calculus was assessed using the Volpe-Manhold Index. Oral soft tissue status was assessed throughout the course of the study. At the conclusion of the study 964 subjects had completed the trial: 486 using the zinc citrate dentifrice and 478 using the control. The results showed that the mean calculus scores in the group using the dentifrice containing zinc citrate were 13.7% lower than those of the group using the control dentifrice. This finding was statistically significant (P less than 0.05). No adverse effects related to the use of either dentifrice were observed.

Results from a three-year caries clinical trial comparing NaF and SMFP fluoride formulations.

A three-year, double blind, randomised clinical trial was conducted in Polk County, Florida from 1983-1987. The objective was to compare the effect of four dose levels of sodium monofluorophosphate (SMFP) and a single dose level of sodium fluoride (NaF) on DMFS, DMFT, and DFS Interproximal indices. A total of 8,027 children were examined clinically and radiographically at baseline, and 5,474 children completed the three-year study, which included daily supervised brushing at school. No differences existed at baseline between the five study cells on age or gender distribution, or on any of the dental indices. Results indicated that the 2000 ppm F NaF group had significantly smaller DMFS increment than the 2000 ppm F SMFP group p < 0.005. The 2000 ppm F NaF group demonstrated an 18 per cent (26 per cent for children > 10 years at baseline) reduction in DMFS over the 1500 ppm F SMFP group, the 2500 ppm F group a 15 per cent (19 per cent) reduction, and the 2000 ppm F SMFP a 5 per cent (9 per cent) reduction. Results are strongest in children at greatest risk--older children with previous caries. This study concludes that the anticaries efficacy of SMFP dentifrices rises with increasing fluoride, and that the anticaries efficacy of a 2000 ppm NaF dentifrice is superior to that of a 2000 ppm F SMFP dentifrice, p < 0.005).

Hydrogen peroxide decomposition in the oral cavity.

PURPOSE: To determine the clearance of hydrogen peroxide from the oral cavity of infants (3-4 yrs of age), juveniles (7-12 yrs of age), adults (35-66 yrs of age), and adults with impaired salivary flow (34-71 yrs of age). MATERIALS AND METHODS: In all subjects, the amount of H2O2 present in the oral cavity was assessed following a 1-min brushing period with an experimental dentifrice formulated with 3% hydrogen peroxide for up to 9 mins postbrushing. In addition, the oral clearance of 3% hydrogen peroxide delivered in an experimental dentifrice formulated with 5% baking soda was determined in a control population of adults and adult subjects with impaired salivary flow. RESULTS: Most of the hydrogen peroxide decomposed during brushing, with less than 30% of the prebrushing dose of hydrogen peroxide remaining in the oral cavity after 1 min of brushing. No differences between infants, juveniles, and adults were seen in levels of hydrogen peroxide recovered from the oral cavity after tooth brushing. When a mixture of hydrogen peroxide and baking soda was used for brushing, less than 5% of the hydrogen peroxide was recovered from the oral cavity after 1 min of brushing. In conclusion, clearance of hydrogen peroxide from the oral cavity was very rapid in children, adults, and adults with impaired salivary flow. Decomposition of hydrogen peroxide was enhanced approximately six-fold in adults by the presence of baking soda in the dentifrice. No substantial amount of hydrogen peroxide survived beyond the brushing period, and very little material would be present to interact with soft tissues in the oral cavity after expectorating any remaining dentifrice containing hydrogen peroxide.

Effect of a baking soda-peroxide dentifrice on post-surgical wound healing.

PURPOSE: To investigate the effect of a baking soda-hydrogen peroxide (0.75%) dentifrice on wound healing, plaque formation, gingival inflammation, patient comfort, probing depth, and clinical attachment level following gingival flap surgery. MATERIALS AND METHODS: A randomized, double-blind crossover study involving 25 patients requiring bilateral maxillary gingival flap surgery was completed. The effects of twice daily brushing with a baking soda-hydrogen peroxide dentifrice (Mentadent) or a placebo dentifrice (Crest) were observed over a 28-day post-surgical period. Gingival Index (GI), plaque index (PI), probing depth (PD), clinical attachment level (CAL) and gingival bleeding index (BI) were recorded pre-surgically and at day 28 for each surgical sextant. At days 7 and 14, soft tissue appearance/wound healing (STA) was assessed based on color and edema, PIs were determined and patient comfort was ascertained by report. RESULTS: Post-surgical wound healing was statistically significantly improved at day 7 with the trend continuing to day 14 when Mentadent dentifrice was used as compared to Crest dentifrice. However, there was no statistical difference in the PI values between the test and control dentifrice throughout the study. Use of Mentadent may be an effective aid in the early phase of healing following gingival flap surgery.

The laboratory and clinical safety evaluation of a dentifrice containing hydrogen peroxide and baking soda.

This study reports the laboratory, clinical, and microbiological finding of the safety testing and daily use of a dentifrice delivering 0.75% hydrogen peroxide and 5% baking soda. Laboratory studies using Ca45 labeled teeth and biologically stained teeth confirmed that the dentifrice did not decalcify enamel or bleach teeth. Over the course of a six-month period, 62 subjects using a hydrogen peroxide-baking soda dentifrice and 21 subjects using a control dentifrice were examined for oral soft tissue change and hard tissue alterations. No soft tissue changes attributable to the use of either dentifrice were noted. Experienced clinicians using Trubyte shade guide teeth observed no significant changes to the subjects' anterior teeth following 6 months use of the test dentifrice. Paired discrimination tests revealed that the examiners could distinguish color differences in the shade guide teeth at 0.7%. Microbiological monitoring of the subjects for six months use of their assigned dentifrice and for the following months on the control dentifrice, revealed neither an increased incidence of candida nor increased candida counts.

The effect of supervised brushing on caries inhibition in school age children.

A supervised brushing program was incorporated into a three-year caries clinical trial whose primary objective was to compare the efficacy between two fluoride levels of a dentifrice (1,000 and 1,500 ppm F MFP). For each of the 2,415 children completing the three-year study, the total number of supervised brushing sessions completed was available. Results indicated that children who complied well with the supervised brushing program by participating in at least 70% of the sessions had a significantly lower caries increment in both fluoride levels (p less than .001) than children who did not comply as well. After adjusting for age, sex, and baseline DMFS of the children, as well as the fluoride level received, a multiple regression model showed that supervised brushing further reduced the three year caries increment (p less than .04). The more frequent use of the higher fluoride dentifrice affords the greatest prevention of decay. The conclusion from this study is that compliance with the supervised brushing program resulted in a reduced caries increment regardless of the level of fluoride in the dentifrice.

Validation of the intraoral delta Ip system and use of the system to test the efficacy of Mentadent dentifrice.

Ongoing efforts within the oral care industry to improve dentifrices by the addition of anti-tartar compounds, bicarbonate and other agents, have necessitated the continuing evaluation of new products in order to assure their anti-caries effectiveness. However, clinical evaluation of new products is time consuming, prohibitively expensive and ethically questionable. Recently, a number of intraoral models have been developed that appear to be well-suited to evaluate new products. In the present study, an intraoral system was used that monitors short-term demineralization of surface enamel. Subjects wore appliances that contained Streptococcus mutans-coated blocks of bovine enamel and rinsed first with 15 ml of a 20% slurry of dentifrice and, after 30 minutes, with a 10% sucrose solution. Iodide penetrability (Ip) was determined before and after each intraoral exposure, and the difference, or delta Ip, was taken as the measure of demineralization. The model system responded linearly to increasing concentrations of fluoride in a series of standard dentifrice preparations. Mentadent, a fluoride toothpaste with baking soda and peroxide, was shown to reduce enamel demineralization and to provide protection comparable to a clinically tested dentifrice (Crest Regular). These results established the validity of the delta Ip method, and demonstrated the efficacy of Mentadent according to the criteria established at the ADA Consensus Conference on Intraoral Models in 1990.

The motivational benefits of a dentifrice containing baking soda and hydrogen peroxide.

Twenty-two family practice dentists, in a large metropolitan area, were recruited to act as independent examiners in a study to evaluate the compliance of their patients to accept a good oral hygiene regimen with the use of a fluoride dentifrice, containing hydrogen peroxide and baking soda, dispensed from a dual dispensing package. To evaluate compliance, the dentists attended an orientation seminar and were trained to assess gingival health using the CPITN periodontal probe. Each dentist evaluated the gingival health status of five to seven of his own patients, initially and after one and three months of product use following hygiene instruction and product assignment. One-hundred and thirty-one patients successfully completed the study. After one month of using the hydrogen peroxide/baking soda toothpaste, the mean reduction in bleeding sites was 53%; at three months the reduction was 62%. The hydrogen peroxide/baking soda dentifrice was well accepted by dentist and patient, and a discernible improvement in oral health of the patients was achieved when the product was used in a conscientious oral hygiene program.

Clinical evaluation of anticalculus dentifrices.

One hundred and eighty-seven patients participated in a six-month study to evaluate the calculus-inhibiting effect of a zinc citrate dentifrice compared to Crest Tartar Control and a placebo, Crest Regular. The findings demonstrate a statistically significant calculus prevention benefit over Crest Regular for both Crest Tartar Control and a 2% zinc citrate/silica product. Compared to the control, the zinc citrate product reduced calculus formation by 32.3%, and Crest Tartar Control reduced it by 21.4%. These findings also demonstrate no statistically significant difference in stain or soft tissue status among the three dentifrices. All products were found to be safe to oral tissues and acceptable for taste.