Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
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 gingiva
| Condition(s) | Periodontitis, Wound Heal, Periodontal Pocket, Periodontal Inflammation, Periodontal Attachment Loss |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 di |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Queen Mary University of London |
| Locations | London, United Kingdom; London, United Kingdom |
| Start date | 2025-06-03 |
| NCT ID | NCT06522438 |
| Official listing | https://clinicaltrials.gov/study/NCT06522438 |