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.
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
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
Parallel
Hyaluronic Acid (HA) and Octenidine gel
Combination productA 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)
Procedure/SurgeryFull 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.
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.
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)
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.
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).
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).
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