Cyanoacrylate Adhesive in Impacted Mandibular Third Molars Surgery

Evaluation of Soft Tissue Healing and Microbiological Status in Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars Using Cyanoacrylate Adhesive

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Impacted Mandibular Third Molar
• Intervention / Treatment: Procedure: cyanoacrylate tissue adhesive; Procedure: Silk Sutures

Detailed Description

Surgical removal of impacted mandibular third molars is one of the most common procedures in dental practice. Following surgery, conventional wound closure using sutures is widely employed to support healing. However, this method has several limitations, including difficult surgical access to the posterior oral cavity, tissue trauma during suturing, plaque accumulation around the suture site, and the need for suture removal after surgery. These drawbacks create a need for alternative wound-closure approaches. Recently, the development of biomaterials, particularly cyanoacrylate tissue adhesives has introduced a new strategy that may improve healing and reduce postoperative complications.

Cyanoacrylate tissue adhesives have been reported to possess favorable biological properties, including antibacterial activity, hemostatic capability, biodegradability, and biocompatibility with living tissues. Various cyanoacrylate derivatives have been investigated, ranging from methyl, ethyl, and propyl to butyl and octyl cyanoacrylate, among which butyl and octyl forms demonstrate the most favorable clinical performance.

In oral surgery, cyanoacrylate has been recognized as a useful alternative due to its ability to shorten operative time, reduce postoperative pain, and eliminate the need for suture removal after healing. Lascaz Netto and Macedo (1986) evaluated wound healing in patients using cyanoacrylate for gingival graft fixation and reported significantly reduced surgical time with normal postoperative recovery. Cyanoacrylate adhesives have also been applied for multiple clinical purposes, including periodontal dressing, closure of sinus membrane perforations, fixation of bone fragments in fracture surgery, and peripheral nerve repair. In addition, cyanoacrylate has been proposed for wound closure via primary healing and, more recently, for protection of wounds healing by secondary intention.

Although cyanoacrylate tissue adhesives have been widely studied and applied in medicine, limited evidence exists regarding their effectiveness in supporting soft-tissue healing and their impact on the local oral microbiological environment. Moreover, few studies have directly compared tissue adhesives with conventional suturing across multiple bacterial species using modern analytical techniques. Therefore, this study was conducted to evaluate the soft-tissue healing support provided by cyanoacrylate tissue adhesive compared with traditional sutures through three aspects: common postoperative complications (pain, swelling, and trismus), the rate of soft-tissue healing, and changes in the microbiological profile at the surgical site.

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyanoacrylate Tissue Adhesive; 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; 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.
Active Comparator: Conventional Silk Sutures; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling	Extraoral swelling was assessed by measuring three facial distances (A, B, C) with a measuring tape applied using light pressure to avoid skin indentation, rounded to the nearest millimeter, with the patient in maximum intercuspation. Segment A was measured from the lateral canthus to the angle of the mandible; segment B from the tragus to the corner of the mouth; and segment C from the tragus to the most anterior-inferior point of the chin. Objective swelling was evaluated on postoperative days 3 and 7 by repeating the same measurements and calculating changes from baseline. Subjective swelling was assessed on days 3 and 7 using a modified Visual Analog Scale (VAS; Kiran Khande, 2011), graded from 0 (no swelling) to 5 (extremely severe swelling with limited mouth opening). Higher grades indicated more severe postoperative swelling.	postoperative days 3 and 7
Maximum mouth opening	The patient's maximum mouth opening was measured using a caliper to determine the distance from the incisal edge of the maxillary central incisor to the incisal edge of the corresponding mandibular central incisor on the same side, rounded to the nearest millimeter.	Postoperative days 3 and 7
Microbiological profile	The investigator collected dental plaque samples from the distal surface of the mandibular second molar using a Gracey curette on postoperative day 7 to evaluate the quantity of the following bacteria: Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Treponema denticola, Streptococcus salivarius, Porphyromonas gingivalis, Prevotella moorei, Tannerella forsythia, Peptostreptococcus stomatis, Eikenella corrodens, Prevotella intermedia, Leptotrichia wadei using the PCR technique.	7 days after surgery
Soft-tissue healing	Healing was evaluated according to the modified scoring scale of Hamzani (2018) on postoperative days 3, 7, and 30. During the inflammatory phase, a score ranging from 5 to 8 indicated good healing; in the proliferative phase, scores ranged from 3 to 5; and in the remodeling phase, scores ranged from 2 to 3. A higher score corresponded to better soft tissue healing.	Postoperative days 3, 7, and 30

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Wound closure; Postoperative pain; Oral microbiota; Oral surgery; Periodontal healing; Cyanoacrylate tissue adhesive; impacted mandibular third molar; Silk suture; Soft-tissue healing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: IRB-VN01002/IRB00010293 (Other Grant/Funding Number: University of Medicine and Pharmacy at Ho Chi Minh City)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No