Randomized Clinical Trial of a Topical Botanical Patch for the Adjunctive Management of Periodontitis.
Academic Article
Overview
abstract
PURPOSE: This randomized, controlled clinical trial aimed to evaluate the clinical, adjunctive effects of an approved botanical barrier device or patch on probing parameters in patients with periodontitis. MATERIALS AND METHODS: Eighty patients with periodontitis were recruited for this single-blinded trial. Patient demographic data, including gender, age, self-reported smoking status, and history of diabetes or cardiovascular disease, were collected. At baseline, all patients received a full-mouth probing examination followed by scaling and root planing (SRP). Thereafter, patients were randomized to receive either adjunctive botanical patch applications (i.e. at 2-4 treatment sites with baseline pocket depth PD ≥6 mm) or no additional therapy (SRP alone, control). Patients applied botanical patch devices per randomization to treatment sites three times on day 0 and once daily on days 1-6. Study devices were spontaneously shed or removed by the patient at 2-2.5 h after each application. Patients were recalled for probing reexaminations at 1, 2 and 3 months. Statistical analyses focused on intergroup differences in probing parameters and included ANOVA for baseline measures and ANCOVA controlling for baseline measures at 1, 2 and 3 months in the overall population and in subpopulations (e.g. smokers vs nonsmokers). RESULTS: Randomized patient groups were balanced with respect to baseline periodontal status (mean and extent PD) but not smoking, with statistically significantly more smokers clustering in the control group (p = 0.002). For the overall population and the non-smoking subpopulation, statistically significantly improved PD and clinical attachment levels (CAL) were observed with adjunctive botanical patch therapy vs control at 1 and 2 months (p < 0.05) but not 3 months (p = 0.08 for PD). For smokers, no statistically significant intergroup differences in PD or CAL were detected with botanical patch treatment. CONCLUSIONS: The data from this trial indicate short-term improvements in probing parameters with the botanical patch device when used adjunctively with SRP, especially with non-smoking periodontitis patients.
