NCT06522438

Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis
• Wound Heal
• Periodontal Pocket
• Periodontal Inflammation
• Periodontal Attachment Loss

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Hyaluronic Acid (HA) and Octenidine gel	A thermosensitive gel with Hyaluronic Acid (HA) and Octenidine (Pocket-X®, Geistlich, Wolhusen, Switzerland) will be applied in the periodontal pockets ≥5mm immediately after the subgingival PMPR, by means of a pre-filled syringe bearing a thin plastic tip and following manufacturer's instructions.
PROCEDURE	Non-surgical periodontal treatment (NSPT)	Full mouth supragingival professional mechanical plaque removal (PMPR) and subgingival PMPR at sites with PPD ≥4mm will be performed with the aid of manual and power-driven instruments under local anaesthesia.

Timeline

• Start date: 2025-06-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-07-26
• Last updated: 2026-02-05

Locations

2 sites across 1 country: United Kingdom