Status:
RECRUITING
Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
Lead Sponsor:
Queen Mary University of London
Conditions:
Periodontitis
Wound Heal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06522438
Start Date
June 3 2025
End Date
December 31 2026
Last Update
July 10 2025
Active Locations (2)
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1
Centre for Oral Clinical Research (COCR)
London, United Kingdom, E1 2AD
2
The Royal London Dental Hospital, Barts Health NHS Trust
London, United Kingdom, E1 2AD