Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-23 @ 10:36 PM
Study NCT ID:
NCT05282615
Status:
None
Last Update Posted:
2023-02-02 00:00:00
First Post:
2022-02-16 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: