Clinical Research Directory

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

The treatment of black triangles in modern dentistry involves various approaches, both surgical and nonsurgical. Surgical methods aim to reconstruct or preserve gingival tissue using techniques such as soft tissue flaps or augmentation. Some invasive surgical methods proposed for papilla reconstruction and correction of black triangle recession include repeated interproximal curettage, Beagle's pedicle graft procedure, free epithelialized and de-epithelialized gingival grafts, and subepithelial connective tissue grafts. The success rate of surgical augmentation depends on the thickness of the gingiva biotype. Orthodontic treatment can also be used to reshape and decrease the embrasure space. An alternative option is minimally invasive procedures for tissue re-volumizing and papilla anatomical-functional reconstruction. Hyaluronic acid (HA) has been used for minimally invasive papilla reconstruction, leveraging its volumizing filler effect. Non-surgical strategies based on hyaluronan are gaining ground internationally. The immediate goal of minimally invasive treatment for interdental papilla loss and black triangle disease is mechanical protection and gingival restoration. Promoting tissue hydration, fibroblast vitality, and collagen deposition may offer a long-term regenerative medicine solution. Additionally, natural-origin, High Purification Technology Polynucleotides (PN HPTTM) are exploited for wound healing and counteracting connective tissue depletion. PNs-based medical devices are widely used in Europe and other countries for various indications, including orthopedics (intra-articular administration), dermatology (intra-dermal injections), and vulvo-vaginal application. PNs have minimal protein contaminants and allergic risks due to advanced purification techniques. Their hydrophilic nature provides hydration and acts as a volume enhancer. Recent in vitro studies demonstrate improved gingival fibroblast viability and collagen deposition with PNs. The purpose of this clinical investigation is to assess the safety and clinical performance of RDM36 in the treatment of periodontal gingival contraction and in black triangles syndrome (BTS).

Clinical Evaluation of Different Treatments for Interdental Black Triangles

This randomized clinical trial aims to evaluate and compare the effectiveness of surgical and nonsurgical treatment approaches for the management of interdental black triangles. Black triangles are open gingival embrasures caused by the loss or deficiency of the interdental papilla between adjacent teeth. These spaces are a common esthetic concern and may also contribute to food impaction and periodontal problems. Thirty adult patients presenting with interdental papillary loss classified as Nordland and Tarnow Class I or II will be recruited from the outpatient clinics of the Faculty of Dentistry at King Salman International University. Eligible participants will be randomly assigned to one of three treatment groups: surgical reconstruction using the tube grafting technique, papillary augmentation using hyaluronic acid injection, or a restorative approach using the injection molding composite technique. Clinical and photographic assessments will be performed at baseline and during follow-up visits at 3 and 6 months after treatment. The primary outcomes will be the reduction in black triangle surface area and height. Secondary outcomes will include clinical periodontal parameters such as plaque index, bleeding score, probing pocket depth, and clinical attachment level. Patient satisfaction with the esthetic outcome will also be evaluated using a Visual Analog Scale (VAS). The findings of this study are expected to provide evidence regarding the comparative effectiveness of surgical and nonsurgical approaches for the management of interdental black triangles and help clinicians select the most predictable treatment modality for improving esthetic outcomes.