Status:
NOT_YET_RECRUITING
Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
Lead Sponsor:
Colgate Palmolive
Collaborating Sponsors:
The University of Texas Health Science Center, Houston
Conditions:
Gingival Inflammation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 i...
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 enrollm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06966492
Start Date
October 1 2025
End Date
July 1 2026
Last Update
July 31 2025
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