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.
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
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
Queen Mary University of London
Lead sponsor