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.

Impact of periodontal therapy on general health: evidence from insurance data for five systemic conditions.

BACKGROUND: Treatment of periodontal (gum) disease may lessen the adverse consequences of some chronic systemic conditions. PURPOSE: To estimate the effects of periodontal therapy on medical costs and hospitalizations among individuals with diagnosed type 2 diabetes (T2D); coronary artery disease (CAD); cerebral vascular disease (CVD); rheumatoid arthritis (RA); and pregnancy in a retrospective observational cohort study. METHODS: Insurance claims data from 338,891 individuals with both medical and dental insurance coverage were analyzed in 2011-2013. Inclusion criteria were (1) a diagnosis of at least one of the five specified systemic conditions and (2) evidence of periodontal disease. Subjects were categorized according to whether they had completed treatment for periodontal disease in the baseline year, 2005. Outcomes were (1) total allowed medical costs and (2) number of hospitalizations, per subscriber per year, in 2005-2009. Except in the case of pregnancy, outcomes were aggregated without regard to reported cause. Individuals who were treated and untreated for periodontal disease were compared independently for the two outcomes and five systemic conditions using ANCOVA; age, gender, and T2D status were covariates. RESULTS: Statistically significant reductions in both outcomes (p<0.05) were found for T2D, CVD, CAD, and pregnancy, for which costs were lower by 40.2%, 40.9%, 10.7%, and 73.7%, respectively; results for hospital admissions were comparable. No treatment effect was observed in the RA cohorts. CONCLUSIONS: These cost-based results provide new, independent, and potentially valuable evidence that simple, noninvasive periodontal therapy may improve health outcomes in pregnancy and other systemic conditions.

Association of a common genetic factor, PTGER3, with outcome of periodontal therapy and preterm birth.

BACKGROUND: Clinical evidence suggests an association between preterm birth and periodontal disease. This study explores whether specific genetic polymorphisms are associated with success of periodontal therapy in pregnant women with periodontal disease and, further, whether any of these same polymorphisms are also associated with spontaneous preterm birth (sPTB). METHODS: One hundred sixty high-risk pregnant women (6 to 20 weeks of gestation) with periodontal disease (≥ 3 sites with attachment loss ≥ 4 mm) were studied. All women received scaling and root planing plus oral hygiene instruction. Periodontal examinations were performed before treatment and 20 weeks later. Participants were classified according to two study outcomes: 1) success or failure of periodontal treatment; and 2) presence or absence of sPTB. Maternal DNA samples from mucosal swabs were characterized using a 1536-SNP (single-nucleotide polymorphism) custom polymerase chain reaction chip. A probabilistic model of each dichotomous outcome, derived using a stepwise Bayesian procedure, was compared to respective null hypotheses on the basis of Monte Carlo simulations and significance estimates obtained using three measures (z-test, Welch t-test, and probability convolution). The models were further confirmed by logistic regression analyses. RESULTS: The models revealed a significant relation between a specific polymorphism of prostaglandin E receptor 3 (a gene associated with inflammatory response) and both periodontal treatment failure (odds ratio 11.09, P <0.0002) and sPTB (odds ratio 6.89, P < 0.0032). CONCLUSIONS: These results demonstrate that the risk of unsuccessful periodontal treatment is associated with tag SNPs in specific genes that regulate the inflammatory response, one of which is also associated with sPTB.

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 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.

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.

Expected estimating equations for missing data, measurement error, and misclassification, with application to longitudinal nonignorable missing data.

Missing data, measurement error, and misclassification are three important problems in many research fields, such as epidemiological studies. It is well known that missing data and measurement error in covariates may lead to biased estimation. Misclassification may be considered as a special type of measurement error, for categorical data. Nevertheless, we treat misclassification as a different problem from measurement error because statistical models for them are different. Indeed, in the literature, methods for these three problems were generally proposed separately given that statistical modeling for them are very different. The problem is more challenging in a longitudinal study with nonignorable missing data. In this article, we consider estimation in generalized linear models under these three incomplete data models. We propose a general approach based on expected estimating equations (EEEs) to solve these three incomplete data problems in a unified fashion. This EEE approach can be easily implemented and its asymptotic covariance can be obtained by sandwich estimation. Intensive simulation studies are performed under various incomplete data settings. The proposed method is applied to a longitudinal study of oral bone density in relation to body bone density.

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.

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.

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.

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.

Periodontal disease and upper genital tract inflammation in early spontaneous preterm birth.

OBJECTIVE: To estimate the relationship between maternal periodontal disease and both early spontaneous preterm birth and selected markers of upper genital tract inflammation. METHODS: In this case-control study, periodontal assessment was performed in 59 women who experienced an early spontaneous preterm birth at less than 32 weeks of gestation, in a control population of 36 women who experienced an early indicated preterm birth at less than 32 weeks of gestation, and in 44 women with an uncomplicated birth at term (>or = 37 weeks). Periodontal disease was defined by the degree of attachment loss. Cultures of the placenta and umbilical cord blood, cord interleukin-6 levels, and histopathologic examination of the placenta were performed for all women. RESULTS: Severe periodontal disease was more common in the spontaneous preterm birth group (49%) than in the indicated preterm (25%, P =.02) and term control groups (30%, P =.045). Multivariable analyses, controlling for possible confounders, supported the association between severe periodontal disease and spontaneous preterm birth (odds ratio 3.4, 95% confidence interval 1.5-7.7). Neither histologic chorioamnionitis, a positive placental culture, nor an elevated cord plasma interleukin-6 level was significantly associated with periodontal disease (80% power to detect a 50% difference in rate of histological chorioamnionitis, alpha = 0.05). CONCLUSION: Women with early spontaneous preterm birth were more likely to have severe periodontal disease than women with indicated preterm birth or term birth. Periodontal disease was not associated with selected markers of upper genital tract inflammation. LEVEL OF EVIDENCE: II-2

Comparison between subtraction radiography and conventional radiographic interpretation during long-term evaluation of periodontal therapy in Class II furcation defects.

BACKGROUND: Limited information comparing digital subtraction radiographic assessment with conventional radiographic interpretation is available from longitudinal clinical trials. The aim of this study was to evaluate the ability to detect periodontal bone changes during the long-term maintenance of Class II furcation defects by conventional radiographic interpretation compared to interpretation of digital subtraction images. METHODS: Standardized radiographs of 18 Class II furcation defects in mandibular molars were taken at baseline and at 6, 12, 18, and 24 months after non-resective periodontal surgery. Conventional radiographic and digital subtraction interpretations were performed masked, respectively, by two and three experienced examiners, according to the following categories: bone gain; bone loss; unchanged appearance; and impossible to visualize. Percent concordance and the kappa statistic value (kappa) were computed. RESULTS: Conventional radiographic and digital subtraction interpretation images resulted in 72 decisions for each examiner. The visual interpretation of digital subtraction images by two examiners revealed the same results. The interpretation of conventional radiographic images showed a low concordance between examiners (kappa < 0.40) at all examinations. The concordance between subtraction radiography and conventional radiographic interpretation was also low for all examiners (kappa < 0.36) at all examinations. Using subtraction radiography as a reference, bone changed and bone unchanged were diagnosed correctly in 47.2% of cases by examiner A, in 43.1% by examiner B, and in 38.9% by examiner C. CONCLUSION: It can be concluded that conventional radiographic interpretation is a more subjective and inaccurate method of detecting periodontal bone changes in Class II furcation defects in mandibular molars when compared with subtraction radiography.