Influence of gender on periodontal outcomes: A retrospective analysis of eight randomized clinical trials.

AIMS: To explore the influence of gender on periodontal treatment outcomes in a dataset of eight RCTs conducted in Brazil, United States, and Germany. METHODS: Clinical parameters were compared between men and women with stages III/IV grades B/C generalized periodontitis at baseline and 1-year post-therapy, including scaling and root planing with or without antibiotics. RESULTS: Data from 1042 patients were analyzed. Men presented a tendency towards higher probing depth (p = .07, effect size = 0.11) and clinical attachment level (CAL) than women at baseline (p = .01, effect size = 0.16). Males also presented statistically significantly lower CAL gain at sites with CAL of 4-6 mm at 1-year post-therapy (p = .001, effect size = 0.20). Among patients with Grade B periodontitis who took antibiotics, a higher frequency of women achieved the endpoint for treatment (i.e., ≤4 sites PD ≥5 mm) at 1 year than men (p < .05, effect size = 0.12). CONCLUSION: Men enrolled in RCTs showed a slightly inferior clinical response to periodontal therapy in a limited number of sub-analyses when compared to women. These small differences did not appear to be clinically relevant. Although gender did not dictate the clinical response to periodontal treatment in this population, our findings suggest that future research should continue to explore this topic.

Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach.

OBJECTIVE: The selection of proper outcome measures is a critical step in clinical research. Most randomized clinical trials (RCTs) assessing the effects of initial anti-infective periodontal therapies use surrogate outcomes as primary outcome variables, such as mean changes in probing depth (PD) or in clinical attachment. However, these parameters do not reflect disease remission/control at patient level, which has led to subjective interpretations of the data from RCTs and Systematic Reviews. Based on a comprehensive analysis of 724 patients from USA, Germany and Brazil treated for periodontitis, this paper suggests that the clinical endpoint of "≤4 sites with PD≥5mm" is effective in determining disease remission/control after active periodontal treatment and therefore, may represent a pertinent endpoint for applying the treat-to-target concept in RCTs. Furthermore, regression models showed that the presence of >10% and >20% sites with bleeding on probing in the mouth post-treatment increases the risk of a patient leaving the endpoint from 1-2 years (OR=3.5 and 8.7, respectively). Researchers are encouraged to present results on this outcome when reporting their trials, as this will allow for an objective comparison across studies and facilitate systematic reviews, and consequently, the extrapolation of data from research to clinical practice.

Tetracycline fibers as an adjunct in the treatment of nifedipine-induced gingival enlargement.

BACKGROUND: The hypothesis that nifedipine-induced gingival enlargement in periodontitis patients can be treated with the adjunctive use of tetracycline (TCN) fibers was tested in this study. METHODS: Ten patients (mean age 66 +/- 4 years) with chronic periodontitis combined with nifedipine-induced gingival enlargement participated. Full mouth recordings of clinical parameters (probing depth, clinical attachment level, bleeding on probing, presence or absence of plaque) were assessed at baseline and gingival enlargement was estimated from casts. Participants were instructed in proper oral hygiene and received supragingival scaling before being reassessed 1 month later. They subsequently received full-mouth scaling and root planing followed by the immediate placement of TCN fibers in all pockets >5 mm. Clinical parameters were reassessed at 3, 6, and 12 months after completion of treatment. RESULTS: TCN fiber placement was well tolerated by patients. All clinical parameters recorded displayed significant improvements after treatment, and they were preserved for the 12-month experimental period. A significant reduction of the percentage of pockets >5 mm was noticed after treatment. The reduction of enlargement was still observed at 12 months despite patients not achieving optimal oral hygiene. CONCLUSION: Placement of tetracycline fibers as an adjunct to mechanical treatment is an option for the non-invasive therapy of nifedipine-induced gingival enlargement in periodontitis patients whose general medical condition and concomitant ailments do not favor a surgical approach.

The effect of aspirin intake on bleeding on probing in patients with gingivitis.

BACKGROUND: Bleeding indices are used as a screen for periodontal disease activity, a measure of disease prevalence, and a measure of effectiveness in clinical trials. Bleeding on probing (BOP) is widely interpreted as a sign of disease activity whereas its absence is interpreted as both a sign and predictor of health. Aspirin use has become increasingly common in the prevention of cerebrovascular and cardiovascular diseases. Because of its anti-platelet activity, aspirin is a non-disease factor that has the potential to affect the appearance of BOP. The hypothesis being tested is that short-term aspirin use in doses of 81 mg and 325 mg will increase the number of bleeding sites in a population with gingivitis. METHODS: Fifty-four subjects were screened initially, those subjects with 20% to 30% whole mouth BOP were randomly assigned to one of three arms: placebo group, 81 mg aspirin group, or 325 mg aspirin group. Before and after exposure to the respective regimens, clinical parameters were measured on all the teeth: the plaque index was recorded at four sites per tooth, and probing depth and BOP were evaluated at six sites per tooth using an automated pressure-sensitive probe. RESULTS: The data obtained in this clinical trial were analyzed utilizing a linear regression analysis to control for confounding variables. The primary measure of interest was BOP in patients clinically demonstrating naturally occurring gingivitis. The results of this study indicate that while controlling for age, gender, and plaque, "low dose" 81 mg and "regular dose" 325 mg of aspirin demonstrated a statistically significant 5.30 (P = 0.001) and 4.13 (P = 0.010) increase from baseline, respectively, in percent BOP. CONCLUSION: Failure to consider the effects of aspirin on BOP could impair proper diagnosis and treatment planning for clinicians and introduce a significant confounding variable in research situations.

The effect of aspirin on the periodontal parameter bleeding on probing.

BACKGROUND: The absence or presence of bleeding on probing (BOP) is a sign of periodontal health or disease, but the presence of BOP is not an accurate predictor of disease progression. Aspirin is increasingly used in the prevention of cerebrovascular and cardiovascular diseases and is a non-disease factor that may modify bleeding indices given its antithrombolytic activity. The purpose of this double-blind placebo-controlled randomized clinical trial was to study the effect of short-term daily aspirin ingestion on the clinical parameter BOP. METHODS: A total of 46 periodontally healthy subjects were included in this study: 16 received placebo, 15 low-dose aspirin (81 mg), and 15 regular dose (325 mg) aspirin. Clinical parameters assessed included plaque index, periodontal probing depth, and BOP using an automated pressure-sensitive probe. Measurements were recorded before and after 7-day exposure to placebo and aspirin regimens. RESULTS: A statistically significant difference in BOP was found in patients with > or = 20% of bleeding sites during the visit prior to placebo or aspirin exposure (n = 11). The group treated with 325 mg aspirin exhibited a moderate yet statistically significant increase in BOP (12.4%) compared to the placebo group (there was no significant difference between the 81 mg aspirin group and placebo). The tendency to bleed was not statistically significant in the group which exhibited <20% (n = 35) of bleeding sites during the visit prior to exposure. CONCLUSION: Aspirin intake of 325 mg daily for 7 days moderately increased the appearance of bleeding on probing in a population that had > or = 20% BOP sites.