Randomized Controlled Clinical Trial To Assess The Safety And Effectiveness Of A Periodontal Hydrogel Wound Dressing (Emanate Perio PODS) On Wound Healing Post-Scaling And Root Planing
McGuire Institute
Summary
The goal of this clinical trial is to compare safety and to see if individuals with generalized stage III periodontitis that are given a periodontal hydrogel dressing on a wound healing after plaque and tartar have been removed from teeth have greater healing than individuals who are given no treatment after.
Description
Periodontitis can be considered a chronic wound, in which the barrier has been compromised allowing pathogenic bacteria to infiltrate the subgingival space. In this study, the Emanate Perio PODS dressing is applied for 30 minutes immediately after toothbrushing and interdental cleaning to physically protect the healing periodontal pocket from pathogenic bacteria while the epithelium reestablishes itself; which usually takes between 15-30 minutes. By week four post SRP, the epithelium matures enough to withstand the mechanical forces and therefore the treatment can stop. It is hypothesized tha…
Eligibility
- Age range
- 30–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all the following criteria to be entered into the study: 1. Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF). 2. Subjects 30 to 75 years of age. 3. Generalized Stage III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥5 mm and ≤7mm, distributed between the mandible and the maxilla, with at least 2 qualifying interproximal sites in each arch. Localized and not more than 6 sites with a PD of 8 mm is acceptable…