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

NCT ID: NCT06966492

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-07-31

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.

Conditions

Gingival Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Control

Regular fluoride toothpaste

Group Type: ACTIVE_COMPARATOR

Stannous Fluoride Toothpaste (SnF)

Intervention Type: DRUG

stannous fluoride toothpaste

Test

Stannous fluoride containing toothpaste

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stannous Fluoride Toothpaste (SnF)

stannous fluoride toothpaste

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and females, between 18-65 years of age;

2. Availability for the duration of the study;

3. 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);

4. Willingness to provide information related to their medical history;

5. Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);

6. Informed Consent Form signed.

Exclusion Criteria

1. 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;

2. Oral pathology or a history of allergy to testing products;

3. 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;

4. Subject participating in any other clinical study;

5. Subject pregnant or breastfeeding;

6. Subject allergic to oral care products and personal care consumer products

7. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;

8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)

9. Current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse;

10. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.

11. Individuals with orthodontic bands or removable partial dentures.

12. Dental prophylaxis in the previous 3 months prior to the baseline examination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Roger Arce, DDS, MS, PhD

Role: CONTACT

Roger.M.Arce@uth.tmc.edu

713 486 4382

Other Identifiers

ILIMSIR

Identifier Type: -

Identifier Source: org_study_id