Prospective, multi-centric, international, single-arm, cohort study to assess a synthetic polyamide suture material in oral surgery to close the mucosa - MUCODA study.
J Dent
; 145: 104922, 2024 06.
Article
en En
| MEDLINE
| ID: mdl-38490322
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. CLINICALSIGNIFICANCE:
This study showed the safe use of a non-absorbable, nylon-based monofilament suture for different oral surgical interventions under daily routine clinical practice.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Suturas
/
Cicatrización de Heridas
/
Técnicas de Sutura
/
Mucosa Bucal
/
Nylons
Límite:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
J Dent
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Reino Unido