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

NCT ID: NCT06522438

Last Updated: 2026-02-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis Wound Heal Periodontal Pocket Periodontal Inflammation Periodontal Attachment Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test Group

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

Group Type EXPERIMENTAL

Hyaluronic Acid (HA) and Octenidine gel

Intervention Type COMBINATION_PRODUCT

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)

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Non-surgical periodontal treatment (NSPT)

Intervention Type PROCEDURE

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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

The Royal London Dental Hospital, Barts Health NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Miljana Bacevic, DDS, PhD

Role: CONTACT

+44 02078823063

Jeniffer Perussolo, DDS, MS, PhD

Role: CONTACT

02078828641

Facility Contacts

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Miljana Bacevic, DDS, PhD

Role: primary

+44(0)207 882 6348

Jeniffer Perussolo, DDS, MS, PhD

Role: backup

02078828641

Miljana Bacevic, DDS, PhD

Role: primary

+44(0)207 882 6348

Jeniffer Perussolo, DDS, MS, PhD

Role: backup

02078828641

Other Identifiers

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346806

Identifier Type: -

Identifier Source: org_study_id

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