Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Re… (NCT06966492) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
United States20 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Gingival Bleeding Index described by Ainamo & Bay, 1976
Timeframe: From enrollment and at each successive visit until to the end of the study