Clinical, microbiological and histological comparison of expanded polytetrafluoroethylene (e-PTFE) and polyglactin 910 (Vicryl) sutures following third molar extraction - A split-mouth prospective, double-blind, randomized, controlled clinical trial

Not Applicable

Conditions: K01.0
K01.1
Embedded teeth
Impacted teeth

Registration Number: DRKS00034216

Lead Sponsor: Klinik für Mund-, Kiefer- und plastische Gesichtschirurgie, Bundeswehrzentralkrankenhaus Koblenz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

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

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound healing of the oral soft tissue<br>- 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 Outcome Measures

Name	Time	Method
- Incidence of complications after 30 days<br>- Qualitative analysis of bacterial colonisation Qualitative comparison of bacterial colonisation for each suture material on the 10th postoperative day after suture removal.<br>- Visual analysis of bacterial colonisation on the 10th postoperative day after suture removal<br>- Histological analysis of the inflammatory reaction on the 10th postoperative day after suture removal<br>- Clinical assessment of suture handling by the surgeon immediately postoperatively and by the examiner on the 10th postoperative day after suture removal<br>- Safety of the suture material by evaluating the suture slack at the end of the operation<br>- Evaluation of patient satisfaction (PROMs) on the 10th postoperative day