Clinical trial NCT06966492: Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
Official title: Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Gingival Inflammation
Keywords: induced gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2025-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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. 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.

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

Primary outcomes:
measure: Gingival Bleeding Index described by Ainamo & Bay, 1976
timeFrame: From enrollment and at each successive visit until to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: