Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.

NCT06966492 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ILIMSIR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Inflammation

Keywords

induced gingivitis

Outcome Measures

Primary Outcomes (1)

• Gingival Bleeding Index described by Ainamo & Bay, 1976

  Gingival Bleeding Index (Ainamo \& Bay, 1976) The six surfaces of teeth will be scored and recorded for absence or presence of bleeding after gentle probing.

  From enrollment and at each successive visit until to the end of the study

Study Arms (2)

Control

ACTIVE COMPARATOR

Regular fluoride toothpaste

Drug: Stannous Fluoride Toothpaste (SnF)

Test

NO INTERVENTION

Stannous fluoride containing toothpaste

Interventions

Stannous Fluoride Toothpaste (SnF) DRUG

stannous fluoride toothpaste

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between 18-65 years of age;
• Availability for the duration of the study;
• ASA 1 Good general health (absence of any self-reported systemic disease or condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
• Willingness to provide information related to their medical history;
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
• Informed Consent Form signed.

You may not qualify if:

• Subjects with more that 2 sites with pocket depth of \> 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone;
• Oral pathology or a history of allergy to testing products;
• Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
• Subject participating in any other clinical study;
• Subject pregnant or breastfeeding;
• Subject allergic to oral care products and personal care consumer products
• Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
• Current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse;
• An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
• Individuals with orthodontic bands or removable partial dentures.
• Dental prophylaxis in the previous 3 months prior to the baseline examination

Sponsors & Collaborators

• Colgate Palmolive: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

UT Health School of Dentistry

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Roger Arce, DDS, MS, PhD

CONTACT

713 486 4382; Roger.M.Arce@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 12, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1)