K01.0 K01.1
Conditions
Interventions
Group 1: The treatment with the respective suture material is randomly assigned (1:1) to one of the two sides (left, right):
- Treatment A/1- (ePTFE)
Group 2: - Treatment B/2 - (Vicryl)
Sponsors
Klinik für Mund-, Kiefer- und plastische Gesichtschirurgie, Bundeswehrzentralkrankenhaus Koblenz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients who require an osteotomy of at least two wisdom teeth with at least 1 tooth per side - Patient age =18 years - Patients with a written declaration of consent
Exclusion criteria
Exclusion criteria: - Patients <18 years of age - Patients with absolute contraindication for surgical interventions - Patients with allergies to medical products/medications - Patients with chronic medication that could affect pain sensation and/or the inflammatory response and/or wound healing - Immunocompromised patients - Existing oral diseases or symptoms that could influence an assessment of the target variables or the efficacy of the preparations, such as existing intraoral infections - Patients without written informed consent - Pregnancy and breastfeeding mothers are also excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing of the oral soft tissue - Comparison of the intraoral wound healing process on both sides using the Early Wound Healing Score (EHS) on the 1st, 2nd and 10th postoperative day. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of complications after 30 days - Qualitative analysis of bacterial colonisation Qualitative comparison of bacterial colonisation for each suture material on the 10th postoperative day after suture removal. - Visual analysis of bacterial colonisation on the 10th postoperative day after suture removal - Histological analysis of the inflammatory reaction on the 10th postoperative day after suture removal - Clinical assessment of suture handling by the surgeon immediately postoperatively and by the examiner on the 10th postoperative day after suture removal - Safety of the suture material by evaluating the "suture slack" at the end of the operation - Evaluation of patient satisfaction (PROMs) on the 10th postoperative day | — |
Countries
Germany
Contacts
Public ContactAnne-Kathrin Bär
Klinik für Mund-, Kiefer- und plastische Gesichtschirurgie, Bundeswehrzentralkrankenhaus Koblenz
Outcome results
None listed