Minimally invasive pouch technique with leukocyte platelet rich fibrin compared to non-invasive hyaluronic acid injection in reconstruction of interdental papilla in esthetic zone: a randomized clinical trial
Résumé
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.
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