Effectiveness of 0.2% hyaluronic acid on clinical, biomolecular and microbiological parameters in type 2 diabetes mellitus patients with periodontitis: a randomized clinical trial

INTERVENTION: This research design is a parallel, double‐blind, placebo‐controlled randomized controlled trial. Subjects consist of two groups: the non‐DM group and the DMT2 group. Subsequently, each group will be randomly divided into test and control groups, with the test groups receiving hyaluronic acid 0.2% gel and the control group receiving a placebo gel. During the first visit, patients will receive an explanation about the research, fill out a screening form, submit their HbA1c test levels, and sign an informed consent to participate. All participants will then undergo clinical parameter examinations of BoP (Bleeding on Probing), PPD (Probing Pocket Depth), and CAL (Clinical Attachment Level). using a UNC‐15 probe (Hu‐Friedy, USA), as well as subgingival plaque and GCF sampling using sterilized no. 25 paper points (Gapadent, China). Following this, scaling and root planing will be performed, and participants will randomly receive either hyaluronic acid gel or placebo gel. Both gels will be inserted into a 1cc syringe with a special tip that is identical and randomly coded by the Pharmacy Faculty of the University of Indonesia (UI FK), ensuring that the operator is unaware of the composition of the syringe. Patients will also receive oral hygiene education, instructions, and identical toothbrushes and toothpaste to use during the research period. The follow‐up visit is scheduled for 4 weeks after the first visit, during which participants will undergo clinical parameter examinations of BoP, PPD, and CAL, and collection of subgingival plaque and GCF samples, without receiving any additional treatment. Plaque samples will be processed in the laboratory using RT‐PCR equipment with 16S rRNA sequencing method using 2‐??CT to demonstrate changes in bacterial abundance in the test CONDITION: Periodontitis with diabetes mellitus ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: At baseline and during the 4‐week follow‐up using clinical examination:; 1. Bleeding on probing; 2. Clinical attachment loss; 3. Pocket probing depth SECONDARY OUTCOME: Quantity of Pg and Fn, and the levels of proinflammatory cytokine, IL‐1ß, and anti‐inflammatory cytokine, IL‐10, obtained from the analysis of subgingival plaque and GCF samples collected at baseline and during the 4‐week follow‐up period. INCLUSION CRITERIA: 1. Age range of 40 to 65 years. 2. Diagnosed with periodontitis according to European Federation of Periodontology (EFP) 3. DM participants are required to obtain medical clearance for SRP treatment. 4. Participants are willing to participate in research and have signed an informed consent