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Efficacy of Microneedling With Hyaluronic Acid Injection for Gingival Augmentation in Thin Gingival Phenotype
This randomized controlled trial adheres to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines and the Declaration of Helsinki ethical principles for medical research. The study complies with Good Clinical Practice (GCP) standards and will be prospectively registered with ClinicalTrials.gov to ensure transparency and accountability. A crossover design is implemented to ensure all participants receive both treatment modalities-microneedling (MN) alone and microneedling combined with injectable hyaluronic acid (MN + HA)-following an appropriate washout period, promoting equitable access while maintaining scientific rigor through within-subject comparisons. Baseline Preparation All enrolled participants receive comprehensive periodontal therapy at baseline, including supragingival and subgingival scaling using ultrasonic instrumentation combined with hand instruments. Standardized oral hygiene protocols are established with identical oral care products provided to each subject, including a soft-bristled toothbrush and interdental cleaning aids. All participants receive instruction in proper brushing technique with emphasis on twice-daily maintenance to ensure consistent plaque control throughout the trial. Microneedling Intervention The MN intervention comprises three sessions spaced seven days apart. Following baseline clinical assessment (plaque index, bleeding on probing, probing depth, clinical attachment level, keratinized tissue width, and gingival thickness) with standardized photographs, topical anesthesia is applied for one minute followed by infiltration anesthesia with 2% lidocaine with 1:100,000 epinephrine. The Dr. Pen Ultima A6 with a 24-pin cartridge is vertically inserted through keratinized gingiva until bone contact is achieved, treating from the mesial central incisor to the distal canine. Treatment ends when uniform pin-point bleeding is achieved. Post-procedure care includes gentle saline rinse, avoidance of brushing for 2
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