Evaluation of comparative efficacy of Platelet Rich Fibrin (PRF) as a membrane versus PRF as a filler using Non-Incised Papilla Surgical Approach (NIPSA) in the management of horizontal bone defects in patients with periodontitis: A single blind randomized controlled trial protocol (Preprint)

BACKGROUND Horizontal bone defects have been neglected by the clinicians due to adverse conditions such as lack of regenerative cells and space maintenance; thus, limiting the clinical outcome. OBJECTIVE The study aims to evaluates efficacy of Platelet Rich Fibrin (PRF) as a membrane versus PRF as a filler in treating horizontal bone defects using the Non-Incised Papilla Surgical Approach (NIPSA). METHODS 26 patients suffering from Stage 2 Grade B chronic periodontitis will be enrolled in this trial and divided equally into two groups. Test groups A received NIPSA with PRF membrane combined with injectable-PRF and demineralized freeze-dried bone allograft (DFDBA) mixture while test group B received only injectable-PRF and demineralized freeze-dried bone allograft (DFDBA) mixture. Clinical parameters such as include plaque index, gingival index, probing pocket depth, gingival recession, relative attachment level, papilla tip location and keratinized tissue width were assessed at baseline, 3 months, 6 months and 9 months. Radiographic parameters which was supra-alveolar attachment gain were assessed at baseline and 9 months. RESULTS The NIPSA will be creating an umbrella pouch which can hold the regenerative materials thus achieving containment of horizontal bone defects resulting in supracrestal bone gain while preserving and elevating the gingivo-papillary complex. CONCLUSIONS The surgical procedure will also improve the esthetic outcome for the patients while reducing pocket depth and long-term tooth survival in periodontally compromised patients. CLINICALTRIAL The protocol has been approved by the institutional ethical committee of Datta Meghe Institute of Higher Education and Research and adheres to the Declaration of Helsinki. Study duration: June 2024–April 2026. (CTRI/2024/06/069193)