Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-01 @ 4:07 PM
Study NCT ID:
NCT06966492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
Sponsor:
Colgate Palmolive
Organization:
Study Overview
Official Title:
Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
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:
ILIMSIR
Brief Summary:
This is a clinical research study designed to measure changes in inflammation and the oral microbiome during a phase of good oral hygiene and the absence of oral hygiene. The goal of the study is to investigate the interplay between local oral inflammation, microbiota and systemic immune responses.
Detailed Description:
An experimental gingivitis model will be used to explore changes in inflammation and the oral microbiome during gingivitis induction and resolution phases. Following consenting, screening, and enrollment, a dental intraoral (IO) scan or "digital impression" will be taken of the maxillary arch of each subject for the construction of an individual 3D printed tooth shield stent for use during the trial period. The customized stent (made of FDA approved resin material) will be used only on the experimental quadrant, and only during tooth brushing to prevent oral hygiene. Biological samples (blood, mucosal swabs, plaque biofilm, saliva, and gingival crevicular fluid) will be collected at each visit (pre-30 days, Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, and Day 28. Plaque and gingivitis examinations will be taken at each visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: