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

NCT05282615 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-02-02

No results posted yet for this study

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

DEVICE

Emanate Tray

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

Sponsors & Collaborators

  • Emanate Biomedical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-01-18
Completion
2023-01-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282615 on ClinicalTrials.gov