Hyaluronic acid and octenidine gel with non-surgical gum treatment
Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment
This pilot will test whether adding a hyaluronic acid and octenidine gel to non-surgical periodontal treatment helps adults with advanced periodontitis heal faster and reduce inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT06522438 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-group pilot will enroll up to 26 adults with stage III/IV periodontitis who will receive either standard non-surgical periodontal treatment (NSPT) alone or NSPT plus a thermosensitive gel containing hyaluronic acid and octenidine. Participants will attend 7–8 visits and be followed for up to three months to collect clinical measures, patient-reported outcomes, gingival crevicular fluid biomarkers, bacterial load, and soft tissue contour changes. Gingival blood flow will be measured using laser speckle contrast imaging to capture early wound-healing events. The purpose is to detect biological and clinical signals of improved early healing that could inform larger trials.
Who should consider this trial
Good fit: Adults aged 18 or older with stage III or IV periodontitis, at least one site per quadrant with probing depth ≥5 mm and attachment loss, good plaque control, non-smokers, and able to attend multiple visits are ideal candidates.
Not a fit: People with known allergy to the product components, current or recent smokers, pregnant or breastfeeding individuals, those with uncontrolled systemic disease (e.g., diabetes), or those needing antibiotic prophylaxis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the adjunctive gel could speed early wound healing, lower inflammation, and improve clinical periodontal outcomes after non-surgical treatment.
How similar studies have performed: Smaller studies have shown hyaluronic acid can support periodontal wound healing while antiseptics like octenidine are less well studied in this context, so the specific combination and gel formulation remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 treatment within the last 12 months * Other severe acute or chronic medical or psychiatric condition or psychological disorder, including limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed, or any additional conditions which, in the judgement of the investigator, would make the subject inappropriate for entry into this trial
Where this trial is running
London and 1 other locations
- Centre for Oral Clinical Research (COCR) — London, United Kingdom (Recruiting)
- The Royal London Dental Hospital, Barts Health NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jeniffer Perussolo, DDS, MS, PhD — Qmul
- Study coordinator: Miljana Bacevic, DDS, PhD
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
- Phone: +44 02078823063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.