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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Wound Heal; Periodontal Pocket; Periodontal Attachment Loss; Periodontal Inflammation
• Intervention / Treatment: Combination product: Hyaluronic Acid (HA) and Octenidine gel; Procedure: Non-surgical periodontal treatment (NSPT)

Detailed Description

This is a parallel-group, pilot study aiming that consists of 7 visits over a minimum period of 4 months. Up to 26 periodontitis patients presenting with periodontal pockets of 5 mm or more will be recruited at the Centre for Oral Clinical Research (COCR) at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miljana Bacevic, DDS, PhD; Phone Number: +44 02078823063; Email: BHNT.Clinicaloralresearchcentre@nhs.net
• Study Contact Backup: Name: Jeniffer Perussolo, DDS, MS, PhD; Phone Number: 02078828641; Email: j.perussolo@qmul.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2AD
    • Recruiting
    • Centre for Oral Clinical Research (COCR)
    • Contact: Jeniffer Perussolo, DDS, MS, PhD; Phone Number: 02078828641; Email: j.perussolo@qmul.ac.uk
    • Contact: Miljana Bacevic, DDS, PhD; Phone Number: +44(0)207 882 6348; Email: BHNT.Clinicaloralresearchcentre@nhs.net
  • London, United Kingdom, E1 2AD
    • Recruiting
    • The Royal London Dental Hospital, Barts Health NHS Trust
    • Contact: Jeniffer Perussolo, DDS, MS, PhD; Phone Number: 02078828641; Email: j.perussolo@qmul.ac.uk
    • Contact: Miljana Bacevic, DDS, PhD; Phone Number: +44(0)207 882 6348; Email: BHNT.Clinicaloralresearchcentre@nhs.net
    • Principal Investigator: Jeniffer Perussolo, DDS, MS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.	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.
Active Comparator: Control Group; Non-surgical periodontal treatment (NSPT) alone.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the expression of GCF wound healing biomarkers	Changes in the expression of GCF wound healing biomarkers at 1, 7, 15, 30 days and 3 months following treatment will be assessed. A subset of analytes involved in the healing process and signalling pathways such as i) inflammation/immune response (e.g., IL-1 β, IL-1 α, IL-6, IL-8, IL-4, IL-10,IL-17, TNF- α, MMP-1, MMP-8, MMP-9, TIMP-1), ii) bone formation/resorption (e.g., TGF- β, osteocalcin, osteopontin, osteoprotegerin, BMP-2), iii) oxidative stress (e.g., Myeloperoxidase), and iv) angiogenesis (e.g., VEGF, angiopoietin-1) will be selected based on the pathways identified and optimized in the genomic and proteomic work from our group. Multiplex immunoassays will be designed specifically for quantitative analyses in the GCF for the 2 groups at the different time points.	Baseline, 1, 7, 15, 30 days and 3 months following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Blood flow	Changes in the blood flow at 1, 7, 15, and 30 days following treatment, evaluated with Laser Speckle Contrast Imaging (LSCI)	Baseline and at 1, 7, 15, and 30 days following treatment.
Changes in the bacterial load	Changes in the bacterial load associated with treated sites at 7, 15, 30 days, and 3 months following intervention. Subgingival plaque samples will be analysed using next generation marker DNA sequencing to characterise the subgingival microbiota to identify and determine the levels of key periodontal bacterial pathogens and microbial community-wide changes in sites treated at the different time points.	Baseline and at 7, 15, 30 days and 3 months following treatment.
Changes in the probing pocket depth (PPD)	PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).	Baseline and at 3 months after intervention
Changes in the gingival recession (REC)	REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).	Baseline and at 3 months after intervention
Changes in the clinical attachment level (CAL)	CAL will be calculated considering the values for PPD and REC in mm	Baseline and at 3 months after intervention
Changes in the Full mouth plaque score (FMPS)	FMPS will be recorded as a percentage of total surfaces (6 sites per tooth), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).	Baseline and at 3 months after intervention
Changes in the Full mouth bleeding score (FMBS)	FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).	Baseline and at 3 months after intervention
Changes in the suppuration	Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent).	Baseline and at 3 months after intervention
Soft tissues contour changes	Soft tissues contour changes will be assessed at 1, 7, 15, 30 days, and 3 months following treatment. An intra-oral 3D scanner will be used to capture and monitor soft tissue contour changes during early phase of healing. The obtained images will be then superimposed (baseline and follow-ups) and calculation of linear and volumetric changes of the soft tissue (magnitude of the swelling, changes in shape and volume) will be performed.	Baseline, 1, 7, 15, 30 days, and 3 months following treatment
Changes in the periodontal inflamed surface area (PISA)	The periodontal inflamed surface area (PISA) is expressed in mm2 and will be calculated as the sum of the PPD of BOP-positive sites for the total dentition, which can be easily calculated using routine periodontal charting.	Baseline and at 3 months after intervention
Dentin hypersensitivity	A 100-mm horizontal visual analog scale (VAS) will be used to assess dentine hypersensitivity. The VAS is scored from 0= none to 100= worst dentin hypersensitivity possible and the subject will indicate the degree by marking vertically across the VAS scale.	Baseline, 1, 7, 15, 30 days, and 3 months after procedure
Patient perception about therapy	The extent of discomfort and/or pain experienced will be evaluated using a 100-mm visual analog scale (VAS). The anchors for each end of the scales will be designated as 0=none to 100= worst. The extent of oedema, hematoma, high fever, and interference in daily activities during the initial weeks will also be evaluated in the same way.	1,7 and 15 days after procedure
Global changes in quality of life	Periodontal health and quality of life following periodontal therapy will be measured through specific questionnaire at 3 months after treatment. Questionnaire will include questions to evaluate patient's perception of treatment on their periodontal health and quality of life. Patients will answer by selecting one of the following options: worsened a lot, worsened a little, stayed the same, improved a little, improved a lot, or don't know.	3 months after procedure

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Collaborators: Geistlich Pharma AG
• Investigators: Principal Investigator: Jeniffer Perussolo, DDS, MS, PhD, QMUL

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Hyaluronic Acid; Non-surgical periodontal treatment; Octenidine
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Attachment Loss; Periodontal Pocket; Carbohydrates; Glycosaminoglycans; Polysaccharides; Hyaluronic Acid
• Other Study ID Numbers: 346806

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No