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.

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.

Treatment of localized periodontal disease in pregnancy does not reduce the occurrence of preterm birth: results from the Periodontal Infections and Prematurity Study (PIPS).

OBJECTIVE: The purpose of this study was to test whether treating periodontal disease (PD) in pregnancy will reduce the incidence of spontaneous preterm delivery (SPTD) at < or = 35 weeks of gestation. STUDY DESIGN: A multicenter, randomized clinical trial was performed. Subjects with PD were randomized to scaling and root planing (active) or tooth polishing (control). The primary outcome was the occurrence of SPTD at <35 weeks of gestation. RESULTS: We screened 3563 subjects for PD; the prevalence of PD was 50%. Seven hundred fifty-seven subjects were assigned randomly; 378 subjects were assigned to the active group, and 379 subjects were assigned to the placebo group. Active treatment did not reduce the risk of SPTD at <35 weeks of gestation (relative risk, 1.19; 95% confidence interval [CI], 0.62-2.28) or composite neonatal morbidity (relative risk, 1.30; 95% CI, 0.83-2.04). There was a suggestion of an increase in the risk of indicated SPTD at <35 weeks of gestation in those subjects who received active treatment (relative risk, 3.01; 95% CI, 0.95-4.24). CONCLUSION: Treating periodontal disease does not reduce the incidence of SPTD.

Evidence of a gene-environment interaction that predisposes to spontaneous preterm birth: a role for asymptomatic bacterial vaginosis and DNA variants in genes that control the inflammatory response.

OBJECTIVE: We determined whether an environmental exposure to bacterial vaginosis (BV) modified genetic susceptibilities for spontaneous preterm delivery within genes that regulate the inflammatory response. STUDY DESIGN: Maternal DNA samples and vaginal smears for Gram staining were collected from 743 women (68 preterm births). We used a 1536-single nucleotide polymorphism (SNP) custom chip to study associations between genotype distributions and preterm birth. RESULTS: For 8 SNPs in 3 genes (protein kinase C alpha, fms-like tyrosine kinase 1, and interleukin 6), the odds ratios for preterm birth ranged from 1.9-4.0 among women with susceptible genotypes who were BV positive. The odds ratios for preterm birth were 2.0-5.0 times greater among women who were BV positive than among women who were BV negative. The significance of these differences was demonstrated by logistic regression analyses for genotype/BV interaction. CONCLUSION: These results demonstrate that the risk of preterm delivery that is associated with tag SNPs in genes that regulate the inflammatory response is modified by an environmental exposure such as bacterial vaginosis.

Association between periodontal disease, bacterial vaginosis, and sexual risk behaviours.

BACKGROUND: Both periodontal disease and bacterial vaginosis may cause adverse pregnancy outcomes. This study evaluated the association between periodontal disease and bacterial vaginosis. MATERIALS AND METHODS: Data from 3569 women enrolled in the Longitudinal Study of Vaginal Flora were used. Periodontal disease, defined as greater than three sites with ≥4 mm attachment loss, was assessed by specially calibrated hygienists at baseline. Positive bacterial vaginosis status was based on a Nugent Gram stain score ≥7. Pairs of independent variables were compared with Pearson's χ(2) and risk ratios were calculated through log-binomial regression. RESULTS: Twenty-eight per cent of women with bacterial vaginosis had periodontal disease compared with 22% without , corresponding to 1.29 (95% CI: 1.13, 1.47) times greater risk of periodontal disease among women with bacterial vaginosis. In adjusted analysis the risk ratio dropped to 1.23 (95% CI: 1.08, 1.40). Receptive oral sex with an uncircumcised partner was associated with 1.28 times (95% CI: 0.97, 1.69) the risk for periodontal disease compared with receptive oral sex with a circumcised partner, though the association is not statistically significant. CONCLUSIONS: In this population, there is a small but significant association between periodontal disease and bacterial vaginosis and a possible trend between receptive oral sex with an uncircumcised partner and periodontal disease.

Adverse events and intravenous versus oral bisphosphonate use in patients with osteoporosis and cancer in the U.S.

This observational study utilized a patient-level database of more than 55 million patients and 70 U.S.-based health plans compiled from 2000-2006. Patients diagnosed with osteoporosis or various cancers were categorized according to bisphosphonate use (via IV, oral, or none). Continuous enrollment for at least six months pre- and post-index diagnosis was required. Outcomes of adverse events were defined as inflammatory conditions of the jaw, including osteonecrosis; major jaw surgery for necrotic or inflammatory conditions; or jaw surgeries for malignancies. Propensity scores and multivariate regression analyses were used to determine adjusted odds ratios for adverse events based on IV or oral bisphosphonate use relative to no bisphosphonate use, controlling for patient demographics, co-morbidities, prior dental or oral surgery, physician likelihood of prescribing oral versus IV bisphosphonates, and antibiotic, hormonal treatment, or thalidomide use. Subgroup analyses-excluding patients using oral corticosteroids-were conducted. After controlling for numerous demographic, clinical, and instrumental variables, this study found significant relationships between IV bisphosphonate use and both inflammatory conditions of the jaw and major jaw surgery for necrotic or inflammatory conditions in patients with osteoporosis or various cancers. While no significant relationship was observed for oral bisphosphonates, continued research is warranted to assess the long-term use of the medications and adverse events in patients with osteoporosis.

Evidence, Junk Science, and Hope in a Time of Pandemic: On the Front Lines in Dentistry.

In early 2020, a new health threat arose with symptoms and mode of transmission comparable to severe acute respiratory syndrome (SARS). Both SARS and the new disease, COVID-19, are caused by coronaviruses and share similar characteristics, especially their severity and high mortality rates and an apparently greater likelihood of transmission. Seasonal influenza is caused by numerous and changing groups of viruses and, for most people, is much less serious. The purpose of this article is to help clinicians compare seasonal influenza, SARS, and COVID-19. It discusses what constitutes best evidence in a time of pandemic, describing the hierarchy of evidence. It is intended to assist dental professionals in providing accurate, current information in answer to patients' questions regarding testing and treatment.

Periodontal disease and adverse pregnancy outcomes: is there an association?

OBJECTIVE: We assessed the risk of adverse pregnancy outcomes (preterm birth [PTB], preeclampsia [PRE], fetal growth restriction [FGR], or perinatal death) in women with periodontal disease (PD) compared to those without. STUDY DESIGN: A multicenter prospective cohort study enrolled women from 3 sites between 6 and 20 weeks' gestation. The presence of PD was defined as periodontal attachment loss > or = to 3 mm on 3 or more teeth. The primary binary composite outcome included PRE, PTB, FGR, or perinatal death. Multivariable logistic regression (MVLR) was used to control for confounders. RESULTS: Three hundred eleven patients with and 475 without PD were included. There was no association between PD and the composite outcome, PRE, or PTB in unadjusted analyses. There was no association between PD and the composite outcome (adjusted odds ratio [AOR], 0.81; 95% confidence interval [CI], 0.58-1.15; P = .24), preeclampsia (AOR, 0.71; 95% CI, 0.37-1.36; P = .30), or preterm birth (AOR, 0.77; 95% CI, 0.49-1.21; P = .25) after adjusting for relevant confounders. CONCLUSION: Despite the body of literature suggesting an association between PD and adverse pregnancy outcomes in urban populations, this large prospective study failed to demonstrate an association.

Clinical and histologic assessment of lateral alveolar ridge augmentation using a synthetic long-term bioabsorbable membrane and an allograft.

BACKGROUND: Guided bone regeneration (GBR) is a widely used procedure for augmenting alveolar ridge width prior to placement of endosseous implants. Various graft materials and barrier membranes (non-resorbable and bioabsorbable) have been used in GBR. The aim of this study was to assess the performance of a new bioabsorbable, synthetic polyglycolic acid/trimethylene carbonate (PGA/TMC) barrier membrane with an increased absorption time in conjunction with a combination of assayed demineralized bone matrix and cortical cancellous chips uniformly dispersed in a thermoplastic biologic carrier. METHODS: At 72 potential implant sites in 38 subjects, ridge width at the crest and 4 mm apical to the crest was measured before and 6 months after a GBR procedure using the long-term (LT) PGA/TMC membrane and an allograft in a thermoplastic carrier. Before placement of endosseous implants, 48 biopsy specimens were obtained from the augmentation sites and analyzed histomorphometrically. RESULTS: The GBR procedure increased the mean ridge width at the crest from 2.4 to 5.2 mm. This 216% change from baseline was significant (P <0.001). The mean width 4 mm apical to the crest increased from 4.4 to 7.5 mm, a significant (P <0.001) 174% change. The histomorphometric analysis showed that the biopsy specimens consisted, on average, of 57% bone (36% graft material and 21% new bone) and 43% soft tissue and space. CONCLUSION: Our findings suggest that the LT PGA/TMC barrier membrane, used in conjunction with an allograft, provides lateral alveolar ridge augmentation comparable to that achieved with other materials without the necessity for bone-graft harvesting or a second procedure to remove the barrier membrane.

Osteonecrosis of the jaw: balancing the benefits and risks of oral bisphosphonate treatment for osteoporosis.

Osteoporosis is a major public health problem. Oral bisphosphonates are effective for reducing the risk of osteoporotic fractures and are an important treatment option for patients at risk for this condition. Osteonecrosis of the jaw (ONJ) is uncommon among cancer patients who are receiving high-dose intravenous bisphosphonates and rarely is seen among patients who are taking oral bisphosphonates for osteoporosis. Dentists play an important role in discussing the implications of the overall dental and medical treatment plans with both patients and physicians. The low risk of ONJ with oral bisphosphonates should be balanced against the benefits of osteoporosis therapy.

Periodontal disease and pregnancy outcomes: exposure, risk and intervention.

Despite the many advances in medicine, the rate of preterm birth has not significantly decreased in the United States over the past several decades. In fact, the rate rose in 2003 to more than 12% of all births in the United States. This equates to over half a million premature births in the United States alone. Consequently, the identification of risk factors for preterm birth which are amenable to intervention would have far-reaching and long-lasting effects. There is emerging evidence of a relationship between periodontal health and adverse pregnancy outcomes, particularly preterm birth/preterm low-birth-weight infants. Therefore this chapter explores the putative association between periodontal disease and infant prematurity, as well as the results of intervention studies which treated periodontal disease in order to reduce the incidence of prematurity. Of 31 published studies, 22 show a positive association between premature birth and periodontal disease. Ongoing studies are addressing the efficacy of periodontal treatment for decreasing the incidence of infant prematurity.

Use of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (P-15) in the treatment of class II furcation defects: a clinical and radiographic study in humans.

BACKGROUND: This study compared clinical and radiographic findings for the treatment of Class II furcation defects in human mandibular molars using anorganic bovine-derived hydroxyapatite matrix (ABM)/cell-binding peptide (P-15) or open flap debridement (OFD). METHODS: Twelve subjects showing two comparable Class II furcation defects in their mandibular molars were enrolled. The defects in each subject were assigned randomly to the test (ABM/P-15) or the control (OFD) group. Clinical measurements and standardized radiographs were taken at baseline and 6 to 7 months after surgery. RESULTS: There were no statistically significant differences between the test and control groups for any clinical or radiographic parameter (P >0.05). On comparing the baseline and final measurements, the gain in horizontal clinical attachment level and reduction in gingival recession were significant only in the test group (P < or =0.02), whereas the gain in the vertical clinical attachment level was significant in both groups (P < or =0.04). In the test group, four of 12 sites showed complete closure, and five showed partial closure; in the control group, three defects showed complete closure, and four showed partial closure (P = 0.42). Subtraction radiography revealed similar gains in bone height and increases in mean bone density with both treatments (P >0.05). CONCLUSIONS: ABM/P-15 yielded favorable results in the treatment of Class II furcation defects over a 6-month evaluation period; however, there was no difference compared to OFD. Further studies using a larger sample size are needed to confirm the present findings.

A meta-analytic approach to determine the state of the science on implant dentistry.

Meta-analyses have been widely used to estimate treatment effects in evidence-based dentistry. Few conferences, however, have used a systems approach to assure coherent data management and analysis. The purpose of this section is to describe the data management and statistical analysis for the State of the Science of Implant Dentistry (SSID) conference. This overview includes (a) a description of widely used clinical trial designs for implant dentistry, (b) a description of data management procedures specifically designed for the SSID conference, and (c) a description of the data analysis methodology, including descriptive analyses and meta-analyses. The use of the systems approach facilitated data abstraction and analysis.

Efficacy of bisphosphonates for the control of alveolar bone loss in periodontitis.

Periodontal disease is characterized by periodontal bone loss. For this reason, we conducted a study to test the effect of alendronate (ALN), an inhibitor of bone resorption, on alveolar bone mass. A total of 335 patients with periodontal disease (men = 162, women = 173), aged 30 to 79, were randomized to either placebo or ALN 70 mg once weekly. All patients received prophylaxis at baseline, and at 6, 12, and 18 months. Smokers accounted for 62% of patients, and 71% of the patients had severe periodontal disease. The primary efficacy endpoint was the change in alveolar bone loss (ABL). When all subjects were analyzed, 2 years of treatment with alendronate 70 mg once weekly did not significantly change either ABL or alveolar bone density (ABD) relative to placebo. However, in the subgroup of patients with low mandibular bone mineral density (BMD) at baseline, alendronate significantly reduced bone loss relative to placebo (p < 0.01). No such effect was seen in patients with normal baseline mandibular BMD. The overall and upper gastrointestinal safety and tolerability profile of alendronate after 2 years of treatment was very favorable compared to placebo. No cases of osteonecrosis of the jaw were observed. In summary, in patients with periodontal disease receiving prophylaxis, alendronate 70 mg once weekly was well tolerated, but did not have a detectable effect on alveolar bone loss, except in those patients with low mandibular BMD at baseline.

Safety of oral bisphosphonates: controlled studies on alveolar bone.

PURPOSE: Osteoporosis and osteopenia are characterized by reductions in bone mass and may lead to skeletal fragility and fracture. The latest generation of oral bisphosphonate drugs, including alendronate and risendronate, has been approved for the prevention and treatment of osteoporosis. These medications are chemically absorbed into bone, decreasing osteoclast number and activity and thereby decreasing bone resorption. The purpose of this report is to present safety data from 2 controlled studies in patients receiving oral bisphosphonates. MATERIALS AND METHODS: Study 1 tested the effect of alendronate, an inhibitor of bone resorption, on alveolar bone. A total of 335 patients (162 men and 173 women, aged 30 to 79 years) with moderate or severe periodontal disease were randomized to either placebo or 70 mg alendronate once weekly. Alveolar bone height and safety were assessed over a 2-year period. Study 2 was a longitudinal single-blind controlled design comparing implant success in 50 consecutive patients (210 implants), 25 patients who received bisphosphonate therapy and 25 age-matched control subjects. Implant success and safety, including incidence of osteonecrosis of the jaws (ONJ), was blindly assessed for at least 3 years. RESULTS: In study 1, no cases of ONJ were observed in either treatment group. Furthermore, a trend toward lower incidences of infection and tooth loss was observed in the alendronate group. In study 2, no cases of ONJ were observed in either group, and implant success was greater than 99% in both groups. CONCLUSION: On the basis of 2 controlled clinical studies, oral bisphosphonate usage was not associated with occurrence of ONJ.

The effect of fibronectin and a bone xenograft on regenerative treatment: a feasibility study.

The purpose of this study was to evaluate the ability of fibronectin to augment the regenerative effects of a bovine-derived xenograft in human periodontal defects. Using a parallel arm, randomized double-blind design, 24 patients with an intrabony defect or a Class II furcation defect were randomly assigned to either the experimental group (xenograft plus fibronectin) or the control group (xenograft without fibronectin). Probing attachment level, pocket depth, and gingival recession were measured at baseline and at 12 months after surgery. Both treatment modalities resulted in attachment gain and pocket depth reduction compared with baseline values. Changes in clinical attachment were not significantly different between the groups (gain of 1.5 mm +/- 1.1 mm in the experimental group and 1.3 mm +/- 1.4 mm in the control). Pocket depth reduction was greater in the control (2.3 mm +/- 1.2 mm) than in the experimental group (2.1 mm +/- 1.9 mm). Gingival recession also was greater in the control (0.9 mm +/- 0.6 mm) than in the experimental group (0.6 +/- 1.5 mm). Subtraction radiography revealed no significant differences between the groups when measuring changes in the distance between the cementoenamel junction and the crest of the bone or in the estimated gain in mineralized tissue mass. It was concluded that a significant difference between the regenerative treatment modalities could not be demonstrated within the limitations of the study. Fibronectin appears to have a stabilizing or proliferative effect on the gingival soft tissue by promoting less postoperative gingival recession.

The association between osteoporosis and oral bone loss.

BACKGROUND: Osteoporosis and osteopenia are characterized by reductions in bone mass and may lead to skeletal fragility and fracture. The purpose of this paper is to review studies to determine the relationship between oral bone loss and osteoporosis. In addition, the major modes of therapy for osteoporosis are discussed. METHODS: In this convenience review, papers studying the possible correlation between oral bone loss and osteoporosis in humans, written in the English language since 1983, were reviewed. RESULTS: The methods used to assess oral and systemic bone varied greatly from study to study. Therefore, the results were not amenable to meta-analysis. Thirteen of the 15 studies did show a positive correlation between systemic bone mass and oral bone mass (or bone loss). CONCLUSION: Studies to date indicate a possible correlation between systemic and oral bone loss.

Bisphosphonate therapy improves the outcome of conventional periodontal treatment: results of a 12-month, randomized, placebo-controlled study.

BACKGROUND: Bone loss in periodontitis results from inflammatory reactions that stimulate osteoclastic bone resorption. Bisphosphonates inhibit bone resorption and increase bone mass. This study evaluated the effect of bisphosphonate therapy as an adjunct to non-surgical periodontal treatment in patients with moderate to severe chronic periodontitis. METHODS: Patients were randomized (2:1) to one of two bisphosphonate therapies or placebo for 1 year. All patients received non-surgical periodontal treatment (scaling, root planing) and periodontal maintenance therapy every 3 months. Clinical assessments at baseline and 6 and 12 months included clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP). Periodontal bone mass was assessed by dental radiographs at baseline and 12 months using fractal analysis and digital subtraction radiography (DSR). RESULTS: Seventy patients were randomized, 43 to the bisphosphonate group and 27 to the placebo group. Bisphosphonate therapy significantly improved CAL, PD, and BOP relative to the placebo group during the 6- to 12-month period (CAL, P = 0.0002; PD, P = 0.0156; BOP, P = 0.0079). There was no difference in the change in periodontal bone mass between the bisphosphonate and placebo groups as measured by fractal analysis and DSR. CONCLUSION: These data suggest that bisphosphonate treatment improves the clinical outcome of non-surgical periodontal therapy and may be an appropriate adjunctive treatment to preserve periodontal bone mass.