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

Launched by QUEEN MARY UNIVERSITY OF LONDON · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special gel that contains Hyaluronic Acid and Octenidine can help improve healing when used alongside standard non-surgical treatment for gum disease (periodontitis). The goal is to see if this gel can help the gums heal better and faster by looking at various signs of healing and health in the mouth over a period of three months. A total of 26 participants will be enrolled in the study, and they will either receive the standard treatment alone or the treatment combined with the gel.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of gum disease with certain measurements indicating its severity. They should not have any allergies to the gel's ingredients, be pregnant or recently pregnant, or have certain medical conditions that could affect their participation. If you join the study, you can expect to attend 7 to 8 visits over the three months, where researchers will monitor your progress and collect important information about your gum health. This trial is still in the planning stages and hasn't started recruiting participants yet.

Gender

ALL

Eligibility criteria

• 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