NCT06914596

A Clinical Trial Comparing Overnight and 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP

Randomized Controlled Clinical Trial To Assess The Safety and Effectiveness of A Periodontal Hydrogel Dressing (Emanate Perio PODS) On Wound Healing Post-Scaling and Root Planing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: McGuire Institute · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 and overnight 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 that during the initial phases of healing, i.e., day 1 to day 30, and in the absence of mechanical forces, the epithelium can protect the subgingival pocket, and Emanate Perio PODS dressing is only applied after toothbrushing and interdental cleaning when tissue is exposed to disruptive mechanical forces. The limited use of the device minimizes the burden of use on patients and aligns with recommended twice daily toothbrushing which can improve treatment adherence and compliance.

Conditions

• Periodontitis (Stage 3)

Interventions

Type	Name	Description
DEVICE	Emanate Perio PODS	Emanate Perio PODS used overnight for 14 days post-SRP
DEVICE	Emanate Perio PODS	Emanate Perio PODS used 2x/day for 30 minutes use

Timeline

• Start date: 2026-02-19
• Primary completion: 2026-12-30
• Completion: 2027-01-30
• First posted: 2025-04-06
• Last updated: 2026-03-10

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study