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

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 at 1, 7, 15, and 30 days following treatment, evaluated with Laser Speckle Contrast Imaging (LSCI)

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.

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).

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).

CAL will be calculated considering the values for PPD and REC in mm

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).

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).

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).

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.

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.

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.

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.

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.