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

NCT07198282 | Recruiting

• 1 other identifier: 2025/220
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Morbidity; Oral Surgery; Impacted Mandibular Third Molar

Keywords

Impacted third molar; Flap closure techniques; Cyanoacrylate; Sutureless technique; Surgical drain

Outcome Measures

Primary Outcomes (3)

• 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.

  1, 3, and 7 days after surgery

• 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.

  1, 3, and 7 days after surgery

• Trismus

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

  1, 3, and 7 days after surgery

Secondary Outcomes (2)

• Wound Healing

  7 and 14 days after surgery

• Patient Quality of Life (GOHAI)

  7 days postoperative

Study Arms (4)

Conventional Suturing

EXPERIMENTAL

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

Procedure: Conventional Suturing

Sutureless Technique

EXPERIMENTAL

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

Procedure: Sutureless Technique

Surgical Drain

EXPERIMENTAL

A biocompatible sterile plastic drain is placed to facilitate drainage of blood and fluids from the surgical site

Procedure: Surgical Drain

Cyanoacrylate Tissue Adhesive

EXPERIMENTAL

Cyanoacrylate-based medical tissue adhesive (PeriAcryl®90 High Viscosity) is applied to effectively close the wound edges.

Procedure: Cyanoacrylate Tissue Adhesive

Interventions

Conventional Suturing PROCEDURE

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

Conventional Suturing

Sutureless Technique PROCEDURE

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

Sutureless Technique

Surgical Drain PROCEDURE

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.

Surgical Drain

Cyanoacrylate Tissue Adhesive PROCEDURE

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

Cyanoacrylate Tissue Adhesive

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Rize, Rize Province, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• Kumar MS, Natta S, Shankar G, Reddy SH, Visalakshi D, Seshiah GV. Comparison between Silk Sutures and Cyanoacrylate Adhesive in Human Mucosa- A Clinical and Histological Study. J Int Oral Health. 2013 Oct;5(5):95-100. Epub 2013 Oct 26.

  PMID: 24324311 RESULT

• Sen A, Dhupar V, Akkara F. Analysing inflammatory responses after mandibular third molar extraction: a comparison of suture-less and multiple suture techniques. Oral Maxillofac Surg. 2024 Dec;28(4):1587-1594. doi: 10.1007/s10006-024-01287-2. Epub 2024 Aug 9.

  PMID: 39117914 RESULT

• Madrazo-Jimenez M, Rodriguez-Caballero A, Serrera-Figallo MA, Garrido-Serrano R, Gutierrez-Corrales A, Gutierrez-Perez JL, Torres-Lagares D. The effects of a topical gel containing chitosan, 0,2% chlorhexidine, allantoin and despanthenol on the wound healing process subsequent to impacted lower third molar extraction. Med Oral Patol Oral Cir Bucal. 2016 Nov 1;21(6):e696-e702. doi: 10.4317/medoral.21281.

  PMID: 27475700 RESULT

• Ergul S, Akar GC. Reliability and validity of the Geriatric Oral Health Assessment Index in Turkey. J Gerontol Nurs. 2008 Sep;34(9):33-9. doi: 10.3928/00989134-20080901-05.

  PMID: 18795563 RESULT

• Falci SGM, Guimaraes MTBA, Canarim NM, Falci SE, Martins OBL, de Souza GM, Galvao EL. Comparison of suture and sutureless techniques on postoperative complications after third molar surgery: a systematic review. Clin Oral Investig. 2024 Jan 25;28(1):115. doi: 10.1007/s00784-024-05518-4.

  PMID: 38267703 RESULT

• Santmarti-Oliver M, Bazal-Bonelli S, Sanchez-Labrador L, Beca-Campoy T, Perez-Gonzalez F, Cobo-Vazquez CM, Madrigal Martinez-Pereda C, Meniz-Garcia C. Cyanoacrylate versus suture as flap closure methods in mandibular third molar surgery: a split-mouth randomized controlled clinical study. Med Oral Patol Oral Cir Bucal. 2024 Jul 1;29(4):e458-e467. doi: 10.4317/medoral.26375.

  PMID: 38907642 RESULT

• Genc A, Cakarer S, Yalcin BK, Kilic BB, Isler SC, Keskin C. A comparative study of surgical drain placement and the use of kinesiologic tape to reduce postoperative morbidity after third molar surgery. Clin Oral Investig. 2019 Jan;23(1):345-350. doi: 10.1007/s00784-018-2442-x. Epub 2018 Apr 19.

  PMID: 29675759 RESULT

• Oladega AA, James O, Adeyemo WL. Cyanoacrylate tissue adhesive or silk suture for closure of surgical wound following removal of an impacted mandibular third molar: A randomized controlled study. J Craniomaxillofac Surg. 2019 Jan;47(1):93-98. doi: 10.1016/j.jcms.2018.10.018. Epub 2018 Nov 12.

  PMID: 30501926 RESULT

• Mariani P, Menditti D, Russo D, Laino L. Evaluation of the effectiveness of tube drain on postoperative discomfort in mandibular third molar surgery: prospective randomized split-mouth study. Acta Odontol Scand. 2023 Oct;81(7):528-533. doi: 10.1080/00016357.2023.2205934. Epub 2023 May 13.

  PMID: 37177802 RESULT

MeSH Terms

Interventions

Sutureless Surgical Procedures

Intervention Hierarchy (Ancestors)

Wound Closure Techniques; Surgical Procedures, Operative

Central Study Contacts

Alperen Kalyoncu, Assistant Professor

CONTACT

+905058261967; alperen.kalyoncu@erdogan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors evaluating postoperative morbidity (pain, swelling, trismus, wound healing) and patient quality of life (GOHAI) are blinded to the flap closure technique assigned to each participant. Surgeons and participants are not blinded due to the nature of the surgical interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned to one of four parallel groups to receive different flap closure techniques after impacted mandibular third molar extraction: conventional suturing, sutureless technique, surgical drain, or cyanoacrylate tissue adhesive. Each group is treated simultaneously and outcomes are compared across groups to evaluate postoperative morbidity and patient quality of life.

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 30, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)