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The Effect of Different Flap Closure Techniques on Postoperative Morbidity in Impacted Third Molar Surgery

ConditionsImpacted Mandibular Third MolarPostoperative MorbidityOral Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorRecep Tayyip Erdogan University

About this trial

1\. ABSTRACT This study is a randomized controlled trial comparing the clinical efficacy and safety of four different flap closure techniques in reducing postoperative morbidity (pain, swelling, trismus, wound healing) and improving patient quality of life (GOHAI) following impacted mandibular third molar extraction. The methods include conventional suturing, sutureless technique, surgical drain, and cyanoacrylate tissue adhesive, which are commonly used in oral surgery practice. The study aims to scientifically evaluate the effects of each method on patients and to determine the most appropriate clinical approach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients classified as ASA II, III, or IV.

Known allergy to anesthetic solutions.

Allergy to acrylate.

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Suturing

    Procedure/Surgery

    Wound edges are approximated using 3/0 braided, non-absorbable silk sutures (Doğsan®, Turkey). Standard oral surgery closure technique.

  • Sutureless Technique

    Procedure/Surgery

    The wound is left to heal by secondary intention without using any suturing material.

  • Surgical Drain

    Procedure/Surgery

    A biocompatible sterile plastic drain is placed in the surgical site to facilitate drainage of blood and fluids, helping to reduce edema and hematoma formation.

  • Cyanoacrylate Tissue Adhesive

    Procedure/Surgery

    Cyanoacrylate-based medical tissue adhesive (PeriAcryl®90 High Viscosity) is applied to the wound edges, providing rapid polymerization and effective closure.

Treatment groups

148 Participants
are divided into 4 treatment groups
Group A: Conventional SuturingExperimental treatment 1 intervention
Group B: Sutureless TechniqueExperimental treatment 1 intervention
Group C: Surgical DrainExperimental treatment 1 intervention
Group D: Cyanoacrylate Tissue AdhesiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain

Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10 cm), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse outcomes.

Time frame
1, 3, and 7 days after surgery
2

Swelling (Edema)

Facial swelling will be measured using standardized linear facial measurements between fixed anatomical landmarks (tragus-pogonion, tragus-oral commissure, gonion-lateral canthus). Greater values represent increased swelling.

Time frame
1, 3, and 7 days after surgery
3

Trismus

Maximum interincisal mouth opening (in millimeters) will be measured using a digital caliper. Decreased values represent more severe trismus.

Time frame
1, 3, and 7 days after surgery

Secondary outcomes

1

Wound Healing

Wound healing will be assessed using three clinical parameters: wound edges, oral mucosa color, and wound closure, as described by Madrazo-Jiménez et al. (2016). Each parameter will be categorized as good, acceptable, or bad. Wound edges: * Good = aesthetic, clean, with well-opposed edges. * Acceptable = slightly irregular edges, mild bleeding or erythema. * Bad = irregular edges, moderate or heavy bleeding, exudate, pus, foul odor, or signs of infection. Oral mucosa color: * Good = identical to the surrounding mucosa. * Acceptable = similar to the surrounding mucosa. * Bad = erythematous. Wound closure: * Good = complete closure, no dehiscence. * Acceptable = 1-2 mm dehiscence. * Bad = dehiscence \> 2 mm, open wound, keloid formation, or unaesthetic closure.

Time frame
7 and 14 days after surgery
2

Patient Quality of Life (GOHAI)

Oral health-related quality of life will be assessed using the General Oral Health Assessment Index (GOHAI; score range: 12-60). Higher scores indicate better oral health-related quality of life.

Time frame
7 days postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Recep Tayyip Erdogan University

Lead sponsor

Source ClinicalTrials.gov
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