Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
NCT ID: NCT06522438
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2025-06-03
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Test Group
Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.
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.
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.
Control Group
Non-surgical periodontal treatment (NSPT) alone.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Jeniffer Perussolo, DDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
QMUL
Locations
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Centre for Oral Clinical Research (COCR)
London, , United Kingdom
The Royal London Dental Hospital, Barts Health NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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346806
Identifier Type: -
Identifier Source: org_study_id
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