Evaluation of Safety and Clinical Benefits of Polynucleotide RDM36 for Treating Interdental Papilla and Gum Tissue Deficits

What this Trial Is About

Researchers are evaluating the safety and clinical performance of the medical device RDM36, which contains high purification polynucleotides (PN HPT), in the treatment of periodontal gingival contraction and Black Triangles Syndrome (BTS). The study aims to assess how well RDM36 can restore interdental papilla and marginal soft tissue deficits, providing mechanical protection and promoting tissue hydration, fibroblast vitality, and collagen deposition as a minimally invasive alternative to surgical and orthodontic approaches. Participants will be randomly assigned to receive either RDM36 or a saline solution as a control. Both treatments involve two perpendicular infiltrations (buccal and palatal) of 0.2 ml each. The study includes a 26-week treatment period, during which the effects on the black triangle lesions and gingival tissue will be monitored using photographic documentation, 2D and 3D imaging, and colorimetric evaluation. Throughout the study, participants will undergo evaluations of periodontal health using plaque index, bleeding on probing, recession, and probing depth measurements. Patient-reported outcomes on aesthetic improvement will be collected through visual analogue, global aesthetic improvement, and Likert scales. Safety will be assessed by monitoring for adverse device effects. The total participation duration covers enrollment through the 26 weeks of treatment, with assessments at regular intervals.

Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)