Cyanoacrylate Adhesive in Impacted Mandibular Third Molars Surgery

NCT07445724 | Not Yet Recruiting

• 1 other identifier: IRB-VN01002/IRB00010293
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized clinical trial is to evaluate whether cyanoacrylate tissue adhesive can improve postoperative outcomes compared with conventional silk sutures in patients undergoing surgical removal of impacted mandibular third molars. The main questions it aims to answer is: Is there a difference in wound healing support, soft-tissue conditions, and microbiological outcomes at the surgical site of impacted mandibular third molar extraction between closure with conventional sutures and cyanoacrylate tissue adhesive? Researchers will compare cyanoacrylate tissue adhesive with conventional silk sutures to determine whether the adhesive provides superior postoperative recovery and periodontal outcomes. Participants will:

• Undergo surgical extraction of an impacted mandibular third molar.
• Receive wound closure using either cyanoacrylate tissue adhesive or conventional silk sutures.
• Be followed postoperatively for assessment of pain, swelling, trismus, soft-tissue healing, and periodontal measurements at specified time points.

Conditions

Impacted Mandibular Third Molar

Keywords

impacted mandibular third molar; Cyanoacrylate tissue adhesive; Silk suture; Wound closure; Postoperative pain; Soft-tissue healing; Periodontal healing; Oral microbiota; Randomized controlled trial; Oral surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Patients self-assessed their pain intensity using the modified Visual Analog Scale (VAS) according to Kiran Khande (2011) on postoperative days 3 and 7. Accordingly, pain was graded as follows: grade 0 (no pain), the patient feels normal; grade 1 (mild pain), the patient does not notice the pain unless attention is drawn to it; grade 2 (moderate pain), the patient experiences pain even while concentrating on certain activities; grade 3 (severe pain), the patient feels very uncomfortable but is still able to continue normal daily activities; grade 4 (very severe pain), the patient must discontinue normal activities; and grade 5 (extremely severe pain), the patient must stop all activities and lie down to rest. A higher pain grade indicates a more severe postoperative condition following the surgical intervention.

  postoperative days 3 and 7

Secondary Outcomes (4)

• Swelling

  postoperative days 3 and 7

• Maximum mouth opening

  Postoperative days 3 and 7

• Microbiological profile

  7 days after surgery

• Soft-tissue healing

  Postoperative days 3, 7, and 30

Study Arms (2)

Cyanoacrylate Tissue Adhesive

EXPERIMENTAL

Participants undergoing surgical removal of impacted mandibular third molars receive wound closure using cyanoacrylate tissue adhesive applied to the surgical site according to the manufacturer's instructions. Postoperative care and follow-up procedures are standardized across both study conditions.

Procedure: cyanoacrylate tissue adhesive

Conventional Silk Sutures

ACTIVE COMPARATOR

Participants undergoing surgical removal of impacted mandibular third molars receive conventional wound closure using interrupted silk sutures. Postoperative care and follow-up procedures are identical to those in the cyanoacrylate condition.

Procedure: Silk Sutures

Interventions

cyanoacrylate tissue adhesive PROCEDURE

Following surgical removal of the impacted mandibular third molar, wound closure is achieved by applying cyanoacrylate tissue adhesive along the mucosal margins to approximate the soft tissues without suturing. The adhesive is allowed to polymerize according to the manufacturer's instructions. No sutures are placed at the surgical site. Postoperative care is standardized across study conditions.

Cyanoacrylate Tissue Adhesive

Silk Sutures PROCEDURE

After surgical removal of the impacted mandibular third molar, wound closure is performed using interrupted non-resorbable silk sutures to approximate the mucosal margins. Sutures are removed at the routine postoperative follow-up visit. Postoperative care is identical to that provided in the cyanoacrylate condition.

Conventional Silk Sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older.
• Patients presenting with bilateral mandibular third molars indicated for extraction, with the same level of surgical difficulty according to the Pell-Gregory classification, and an angulation difference between the two teeth not exceeding 15° according to the Winter classification on panoramic radiographs.
• No use of local or systemic antibiotics within 2 weeks prior to surgery.
• Absence of serious systemic diseases such as coagulation disorders or uncontrolled diabetes, and no acute infection at the extraction site.
• Patients who agree to participate in the study after receiving clear explanation and counseling.

You may not qualify if:

• Patients who are uncooperative in providing necessary information or who decline to continue participation in the study.
• A difference in surgical duration between the two sides exceeding 12 minutes, or the occurrence of intraoperative complications.
• Patients with known hypersensitivity or allergy to any materials used in the study, such as lidocaine local anesthetic, cyanoacrylate adhesive, or suture materials.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative outcome assessments are performed by an independent examiner who is blinded to the wound-closure method. Participants and surgeons are not blinded due to the nature of the surgical interventions. Allocation information is concealed during clinical measurements and data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral Surgeon, Department of Oral Surgery, Faculty of Dentistry

Model Details: This study uses a randomized split-mouth design in which each participant undergoes bilateral mandibular third molar surgery. One surgical site is closed with cyanoacrylate tissue adhesive and the contralateral site with conventional silk sutures, with side allocation determined by randomization. Surgeries may be performed at separate visits according to clinical indications.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share