Comparing flap closure methods after impacted lower wisdom tooth removal
The Effect of Different Flap Closure Techniques on Postoperative Morbidity: A Randomized Controlled Trial for Impacted Third Molar Surgery
NA · Recep Tayyip Erdogan University · NCT07198282
This trial will test whether four flap closure methods—traditional sutures, leaving the wound open, a small surgical drain, or a cyanoacrylate tissue adhesive—reduce pain, swelling, limited mouth opening, and improve recovery for healthy adults (18–40) having an impacted lower third molar removed.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Recep Tayyip Erdogan University (other) |
| Locations | 1 site (Rize, Rize Province) |
| Trial ID | NCT07198282 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial that assigns patients to one of four commonly used flap closure techniques following extraction of a similarly positioned impacted mandibular third molar. Outcomes include postoperative pain, facial swelling, trismus (limited mouth opening), wound healing, and patient-reported oral health quality of life (GOHAI) measured at scheduled follow-ups. The four interventions compared are conventional silk suturing, a sutureless approach (secondary intention), placement of a surgical drain, and closure with a high-viscosity cyanoacrylate tissue adhesive. Eligible participants are healthy adults (ASA I) aged 18–40 with specific impaction classifications, and the procedures and follow-ups take place at a single university oral surgery department.
Who should consider this trial
Good fit: Healthy adults aged 18–40 (ASA I) with an impacted mandibular third molar in similar positions (Pell & Gregory Class 2, Position B; vertical or mesioangular) are ideal candidates.
Not a fit: Patients who are older or have systemic illness (ASA II–IV), active local infection, heavy tobacco or alcohol use, pregnancy, anticoagulant or antiplatelet therapy, coagulation or immunosuppressive disorders, or known allergy to acrylates are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the best flap closure method could reduce early postoperative pain and swelling and speed recovery after impacted lower wisdom tooth extraction.
How similar studies have performed: Previous clinical comparisons of sutures versus sutureless closure, tissue adhesives, and drains exist with mixed results—some trials report modest improvements with cyanoacrylate or sutureless techniques but findings are inconsistent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-40 years. * Patients with no systemic diseases (ASA I). * Patients with impacted mandibular third molars indicated for extraction, with bone and/or mucosal retention, in similar positions (Pell \& Gregory Class 2, Position B; Winter classification vertical or mesioangular). Exclusion Criteria: * Patients classified as ASA II, III, or IV. * Known allergy to anesthetic solutions. * Allergy to acrylate. * Pregnant or breastfeeding women. * Individuals with tobacco use ≥10 cigarettes/day. * Alcohol users. * Patients using antiplatelet agents. * Patients using anticoagulants. * Patients with coagulation disorders. * Patients with immunosuppressive diseases or receiving immunosuppressive therapy. Patients with acute pain or local infection at the surgical site.
Where this trial is running
Rize, Rize Province
- Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery — Rize, Rize Province, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Alperen Kalyoncu, Assistant Professor
- Email: alperen.kalyoncu@erdogan.edu.tr
- Phone: +905058261967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Impacted Mandibular Third Molar, Postoperative Morbidity, Oral Surgery, Impacted third molar, Flap closure techniques, Cyanoacrylate, Sutureless technique, Surgical drain