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Impacted Mandibular Third MolarGMC02NCT07198282

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

A study testing Conventional Suturing, Sutureless Technique and Surgical Drain in people with Impacted Mandibular Third Molar and Postoperative Morbidity, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Conventional Suturing, Sutureless Technique and Surgical Drain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 May 2026to 30 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alperen Kalyoncu, Assistant Professor contact

+905058261967

alperen.kalyoncu@erdogan.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

    Rize, Rize Province

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Different Flap Closure Techniques on Postoperative Morbidity: A Randomized Controlled Trial for Impacted Third Molar Surgery

  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.
Read the detailed description
  1. INTRODUCTION Impacted mandibular third molar extraction is a commonly performed surgical procedure. Postoperative morbidity following this procedure can negatively affect patient satisfaction and quality of life. The rationale for this study is to objectively examine the role of flap closure techniques, which are an integral part of the surgical procedure, on these morbidities. The methods investigated in this research were selected due to their potential impact on wound healing and postoperative comfort.
  2. PHYSICAL AND CHEMICAL CHARACTERISTICS OF THE METHODS USED

Surgical Drain Application: A biocompatible, sterile plastic tube used to drain accumulated blood and other fluids from the tissues.

Conventional Suturing Technique: Wound edges are approximated using 3/0 braided, non-absorbable silk suture (Doğsan®, Turkey). Silk suture is biologically inert and provides strong tensile strength.

Cyanoacrylate (PeriAcryl®90 High Viscosity Dental Cyanoacrylate): A cyanoacrylate-based medical tissue adhesive. Its rapid polymerization allows effective closure of wound edges.

Sutureless Technique: No material is used in this method; the wound is left to heal by secondary intention.

  1. NON-CLINICAL STUDIES This study does not involve any investigational product (drug) with systemic pharmacological or toxicological effects. Therefore, no evaluation of pharmacological, toxicological, or pharmacokinetic studies in animals is relevant in this section.
  2. EFFECTS ON HUMANS AND SAFETY-EFFICACY ASSESSMENT All four flap closure techniques are commonly used in oral surgery and have well-known safety profiles.

Conventional Sutures: May cause postoperative pain, swelling, and trismus. The most common adverse events are infection and bleeding.

Cyanoacrylate: Literature reports indicate it may accelerate wound healing and reduce pain. Potential adverse reactions include local irritation or allergic responses.

Surgical Drain: May contribute to wound healing by reducing edema and hematoma formation. Possible adverse events include discomfort at the incision site or infection.

Sutureless Technique: May be associated with increased postoperative pain and swelling. Wound healing may take longer compared to other methods.

This study is designed to compare the safety and efficacy of these methods using a randomized controlled methodology and to determine which method is superior in terms of patient quality of life and morbidity.

  1. MARKETING EXPERIENCE The medical materials used in this study, including cyanoacrylate (PeriAcryl®90) and silk sutures (Doğsan®), are commercially available products approved by relevant regulatory authorities. None of the products have been withdrawn from the market. PeriAcryl®90 has been registered by Intertek, an MDSAP-certified auditing organization, in compliance with ISO 13485:2016 requirements.
  2. SUMMARY OF DATA AND INVESTIGATOR GUIDE As the aim of this study is to compare surgical methods, it is essential that investigators understand the known benefit-risk profile of each technique. The health and safety of volunteers are the top priority.

Potential Risks and Adverse Reactions:

Expected postoperative morbidities such as pain, swelling, and trismus, as well as surgery-specific risks like infection, bleeding, and rarely nerve injury.

Precautions:

All surgical procedures will be performed according to a standardized protocol by experienced surgeons.

Volunteers will be provided with a full and understandable informed consent form detailing all risks and expectations related to the postoperative period.

Regular follow-up visits are scheduled on the 2nd and 7th days for early detection and management of potential complications.

Emergency Management:

In the event of a serious adverse event, such as life-threatening conditions or permanent disability, the protocol procedures will be immediately implemented and reported to the Turkish Medicines and Medical Devices Agency (TITCK).

Being tested
Conventional Suturing, Sutureless Technique, Surgical Drain, Cyanoacrylate Tissue Adhesive
Keywords
Impacted third molar, Flap closure techniques, Cyanoacrylate, Sutureless technique, Surgical drain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional SuturingProcedure or surgery

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

  • Sutureless TechniqueProcedure or surgery

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

  • Surgical DrainProcedure or 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 AdhesiveProcedure or surgery

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

Study groups in NCT07198282
Study groupRoleWhat they receive
Conventional SuturingExperimentalWound edges are approximated using 3/0 braided, non-absorbable silk sutures (Doğsan®, Turkey). Standard oral surgery closure technique.
Receives: Procedure: Conventional Suturing
Sutureless TechniqueExperimentalThe wound is left to heal by secondary intention without any suturing material.
Receives: Procedure: Sutureless Technique
Surgical DrainExperimentalA biocompatible sterile plastic drain is placed to facilitate drainage of blood and fluids from the surgical site
Receives: Procedure: Surgical Drain
Cyanoacrylate Tissue AdhesiveExperimentalCyanoacrylate-based medical tissue adhesive (PeriAcryl®90 High Viscosity) is applied to effectively close the wound edges.
Receives: Procedure: Cyanoacrylate Tissue Adhesive

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 1, 3, and 7 days after surgery

Secondary outcomes (2)
  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.

    Measured: 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.

    Measured: 7 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start8 May 2026
  3. Primary completion15 Aug 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07198282
Sponsor's protocol ID
2025/220
Acronym
GMC02
Status last verified
Jun 2026
First submitted
21 Sep 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data from this study will be made available upon reasonable request to the corresponding author after publication of the primary results. Data sharing will be for research purposes only and will require a signed data sharing agreement to ensure participant privacy and confidentiality

Publications

  • 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.

    PubMed 24324311
  • 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.

    PubMed 39117914
  • 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.

    PubMed 27475700
  • 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.

    PubMed 18795563
  • 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.

    PubMed 38267703
  • 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.

    PubMed 38907642
  • 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.

    PubMed 29675759
  • 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.

    PubMed 30501926
  • 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.

    PubMed 37177802

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Suturing, Sutureless Technique and Surgical Drain in people with Impacted Mandibular Third Molar and Postoperative Morbidity, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alperen Kalyoncu, Assistant Professor (+905058261967, alperen.kalyoncu@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain (time frame: 1, 3, and 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07198282, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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