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

May 22, 2026 updated by: Colgate Palmolive
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77054
        • UT Health School of Dentistry
        • Contact:
          • Roger Arce, Assoc Prof, Dept. of Periodontics & Oral Hygiene, DDS, MS, PhD
          • Phone Number: 713-486-4382
          • Email: rarcemunoz@uth.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Regular fluoride toothpaste
Drug: Stannous Fluoride Toothpaste (SnF)
stannous fluoride toothpaste
No Intervention: Test
Stannous fluoride containing toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Bleeding Index described by Ainamo & Bay, 1976
Time Frame: From enrollment and at each successive visit until to the end of the study

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Collaborators

The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

May 9, 2025

First Posted (Actual)

May 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILIMSIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non personal identifier information included in the results section of the publication. The IPD would be related to the clinical plaque and gingival inflammation data as well as inflammatory marker and microbiome data arising from the analysis of the biological samples.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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