NCT05282615

Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone

A Randomized, Controlled, Proof of Concept Trial of the Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Emanate Biomedical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis. After eligibility determination, subjects will be randomized to the following groups: * Group 1: Full mouth periodontal debridement + Emanate Tray (treatment group) * Group 2: Full mouth periodontal debridement alone (control group) Patients will be evaluated at Baseline and on Days 14, 28, and 56 for primary endpoint and at baseline and on day 56 post-treatment for secondary (efficacy) endpoints.

Conditions

• Wound Heal
• Mouth; Wound
• Periodontal Inflammation

Interventions

Type	Name	Description
DEVICE	Emanate Tray	Emanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-01-18
• Completion: 2023-01-18
• First posted: 2022-03-16
• Last updated: 2023-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study