Prospective, multi-centric, international, single-arm, cohort study to assess a synthetic polyamide suture material in oral surgery to close the mucosa - MUCODA study.

ABSTRACT

OBJECTIVES: The aim was to collect different clinical parameters systematically and proactively regarding safety, effectiveness, and performance of a nylon monofilament suture under routine clinical practice for oral surgery. METHODS: The study design was prospective, bicentric, international, single-armed, and observational. A non-absorbable suture was applied to close the mucosa after different dental surgical interventions. Main objective was the incidence of combined postoperative complications until suture removal. The 95 % Confidence Interval (Agresti-Coull method) was used to prove the non-inferiority with a pre-specified upper margin of 21.9 %. Secondary variables were intraoperative suture handling, patient pain and satisfaction, wound healing, aesthetic appearance, and bacterial contamination. RESULTS: 105 patients were enrolled. Complication rate was low (1.9 %), 2 swellings occurred. Pain was present for 1.61 days ± 1.42 after various dental interventions with an average pain level of 20.98 ± 22.60 (VAS). Patients with impacted third molar extraction showed the longest pain duration (6 days) combined with the highest mean pain level of 35.33 ± 30.45 (VAS). Intraoperative suture handling was very good to excellent. Suture removal was done after an average duration of 7.56 ± 2.09 days. Patient's satisfaction was high, and an excellent wound healing was reported by the dentists. Aesthetic appearance only performed in implant patients was rated by oral surgeons with an average of 96.19 ± 3.79 points [min. 80 - max. 100] at 5 months postoperatively. Thread bacterial analysis showed that F. nucleatum was the most present species. CONCLUSIONS: Our findings indicate that the non-absorbable, nylon-based monofilament suture used is safe and quite suitable for oral mucosal closure after various dental surgical interventions such as tooth extraction, implant placement and impacted third molar extraction. CLINICAL SIGNIFICANCE: This study showed the safe use of a non-absorbable, nylon-based monofilament suture for different oral surgical interventions under daily routine clinical practice.