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

Queen Mary University of London

Status: Enrolling

Conditions: Periodontitis; Periodontal Attachment Loss; Periodontal Pocket; Wound Heal; Periodontal Inflammation

Treatments: Combination Product: Hyaluronic Acid (HA) and Octenidine gel; Procedure: Non-surgical periodontal treatment (NSPT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06522438

346806

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

26 participants in 2 patient groups

Test Group

Experimental group

Description:

Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.

Treatment:

Procedure: Non-surgical periodontal treatment (NSPT)

Combination Product: Hyaluronic Acid (HA) and Octenidine gel

Control Group

Active Comparator group

Description:

Non-surgical periodontal treatment (NSPT) alone.

Treatment:

Procedure: Non-surgical periodontal treatment (NSPT)