Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment (NCT06522438) | Clinical Trial Compass
RecruitingNot Applicable
Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
United Kingdom26 participantsStarted 2025-06-03
Plain-language summary
This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. This will be assessed through the expression of specific gingival crevicular fluid markers, as well as by changes in gingival blood flow (assessed by laser speckle contrast imaging), bacterial load, soft tissues contour, clinical parameters and patient-reported outcomes.
The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust. Patients will be randomised to receive either NSPT alone or NSPT+ HA and Octenidine gel, and will be followed up to 3 months after treatment.
The study will consist of 7- 8 visits.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female aged 18 and above
* Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment, or exhibiting a ≥ 50% reduction in plaque score from the initial screening visit.
* Periodontitis stage III/IV (grades A to C) with at least one site per quadrant with PPD ≥5mm, bleeding on probing and attachment loss ≥5mm
* Willing to sign informed consent and comply with study procedures
Exclusion Criteria:
* Know hypersensitivity and/or allergy to any of the product's component (as per user leaflet)
* Self-reported pregnancy or lactation
* Smoking (current or in past 5 years), including e-cigarettes/vaping
* Medical history including diabetes mellitus or other serious medical/ psychiatric conditions or transmittable diseases that according to the investigator may increase the risk associated with study participation
* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures or/and systemic antibiotic therapy during the 3 months preceding the baseline evaluation
* In chronic treatment with anti-inflammatory (including corticosteroids), anticoagulants/antiplatelets (including aspirin), immunosuppressants or other medication that can severely impact wound healing
* History of alcohol or drug abuse
* Subgingival professional mechanical plaque removal (excluding not-extensive subgingival debridement as judged by the examining clinician) and/or surgical periodontal…
What they're measuring
1
Changes in the expression of GCF wound healing biomarkers
Timeframe: Baseline, 1, 7, 15, 30 days and 3 months following treatment