Hyaluronic Acid and Octenidine gel as an adjunct to NSPT
Research type
Research Study
Full title
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
IRAS ID
346806
Contact name
Jeniffer Perussolo
Contact email
Sponsor organisation
Queen Mary University
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT06522438, NCT number
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Effective treatment of periodontitis involves a stepwise approach aiming to control the dental plaque biofilm and consequently reduce the bacterial load to reduce chronic inflammation and stop disease progression. Although most of patients/sites will respond to Step 1 -2 (non-surgical periodontal treatment - NSPT), some may still present active disease after initial management requiring additional non-surgical or surgical treatment (Step 3).
In order to enhance and modulate the body's natural healing processes, reduce inflammation and inhibiting destructive processes of periodontal tissues, there has been a growing interest in adjunctive treatment options to NSPT. These adjunctive therapies, which can be used alongside conventional treatment (NSPT), target the molecular mechanisms responsible for controlling cellular signalling pathways involved in tissue healing and regeneration. Among them, a novel thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine has been proposed as safe and effective therapeutic strategy adjunct to NSPT, aiming to improve healing in terms of clinical outcomes and to mitigate bacterial regrowth.
This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing HA and Octenidine to NSPT will be able to modulate the early wound healing events, which will be assessed through the expression of specific gingival crevicular fluid markers, as well as through 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.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0122
Date of REC Opinion
25 Mar 2025
REC opinion
Further Information Favourable Opinion