Cyanoacrylate Adhesive in Impacted Mandibular Third Molars Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cyanoacrylate tissue adhesive

    Procedure/Surgery

    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.

  • Silk Sutures

    Procedure/Surgery

    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.

Treatment groups

23 Participants
are divided into 2 treatment groups
Group A: Cyanoacrylate Tissue AdhesiveExperimental treatment 1 intervention
Group B: Conventional Silk SuturesActive comparator 1 intervention

Trial outcomes

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.

Time frame
postoperative days 3 and 7

Secondary outcomes

1

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.

Time frame
postoperative days 3 and 7
2

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.

Time frame
Postoperative days 3 and 7
3

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.

Time frame
7 days after surgery
4

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.

Time frame
Postoperative days 3, 7, and 30

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: