Abstract
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 assess the minimally invasive Pouch technique using Leukocyte Platelet Rich Fibrin compared to non-invasive Hyaluronic acid gel injection in the reconstruction of Interdental papilla in esthetic zone. METHODS: The study was designed as a randomized, controlled, double-blinded, and phase (IV) clinical trial. The trial was registered retrospectively with the date (21/7/2023) and registration number (NCT05953896). A total sample size of 20 cases was planned to be recruited. i.e. (10 patients in each group). Patients with deficient interdental papilla class I or II in the esthetic zone were selected, then patients were randomized using computer-generated block randomization into two equal groups: group A (L-PRF) and group B (HA gel). Blinding was performed in selection of patient intervention, while blinding of the intervention wasn't applicable since both interventions are completely different. 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 in the mean value of black triangle height of the PRF group: (0.9 ± 0.52), and HA group: (0.6 ± 0.46), with no significant difference (P value: 0.178 (ns)) between the two groups at 6 months. No significant difference was found in the primary outcomes, and secondary outcomes between the study groups at 6 months. CONCLUSIONS: Both injectable HA and multilayered L-PRF gave successful results that can be comparable to the invasive surgical techniques.