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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Combination product
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Centre for Oral Clinical Research (COCR)
RECRUITING
London
The Royal London Dental Hospital, Barts Health NHS Trust
RECRUITING
London
Contact Information
Primary
Miljana Bacevic, DDS, PhD
BHNT.Clinicaloralresearchcentre@nhs.net
+44 02078823063
Backup
Jeniffer Perussolo, DDS, MS, PhD
j.perussolo@qmul.ac.uk
02078828641
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 26
Treatments
Experimental: Test Group
Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.
Active_comparator: Control Group
Non-surgical periodontal treatment (NSPT) alone.
Related Therapeutic Areas
Sponsors
Leads: Queen Mary University of London

This content was sourced from clinicaltrials.gov