Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
NCT Number: NCT06522438
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis|Wound Heal|Periodontal Pocket|Periodontal Inflammation|Periodontal Attachment Loss
Interventions: COMBINATION_PRODUCT: Hyaluronic Acid (HA) and Octenidine gel|PROCEDURE: Non-surgical periodontal treatment (NSPT)
Sponsor: Queen Mary University of London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-04
Locations: Centre for Oral Clinical Research (COCR), London, E1 2AD, United Kingdom|The Royal London Dental Hospital, Barts Health NHS Trust, London, E1 2AD, United Kingdom

Summary:
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.

Primary Outcome Measures: 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: 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