Evaluation of minimally invasive Pouch technique with multilayered Leukocyte Platelet Rich Fibrin versus non-invasive Hyaluronic acid gel injection in the reconstruction of Interdental Papilla in the Esthetic Zone: A Randomized Clinical Trial

Abstract

<title>Abstract</title> Background Interdental papilla deficiency is of high concern from the esthetic and functional perspectives. Several invasive approaches have been reported for interdental papilla reconstruction. However, the long-term success of invasive approaches is still controversial, therefore this study aimed to evaluate the efficacy of Hyaluronic acid gel injection compared to multilayered leukocyte platelet-rich fibrin in reconstruction of deficient interdental papillae. Methods In this randomized clinical, double-blinded study, twenty patients with deficient interdental papilla class I or II in the esthetic zone were selected, then patients were randomized into two equal groups: <bold>group A</bold> (Multilayered L-PRF) and <bold>group B</bold> (HA gel). Sample size calculation and power analysis was designed to have adequate power to apply a 2-sided statistical test of the research hypothesis that there is no difference between groups. The predicted sample size (n) was a total of (20) cases. i.e. (10) for each group. The clinical and radiographic parameters were assessed at 3 and 6 months, As well as evaluation of patient satisfaction between the two tested groups. Results Both groups showed significant improvement in all clinical parameters at 3 months and 6 months postoperatively. Assessment of patient satisfaction showed overall improvement in both groups after 6 months, with successful reduction of the black triangle height. Conclusions Both injectable HA and multilayered L-PRF gave successful results and can be safe adjuncts to the invasive surgical techniques. Trial registration: The study was retrospectively registered in an appropriate registry and has been identified with the registration number <bold>(NCT05953896)</bold> with the date of registration (19-7-2023).