Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive; Procedure: closure of wound using braided silk suture

• Registration Number: NCT04898816
• Lead Sponsor: Melaka Manipal Medical College

Brief Summary

This study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. One Group received braided black silk suture and the other group received N-butyl 2-octyl cyanoacrylate tissue adhesives.

Detailed Description

Conventional method of wound closure after removal of impacted mandibular molar is by suturing the wound using braided black silk suture and allowing for primary healing. Suturing in the most posterior region of oral cavity is not easy, it requires more time and additional skills as well. Patient has to come for a second visit for removal of suture. Moreover tight sutures may lead to ischemia and necrosis.

Tissue adhesives adopts the idea of sutureless wound closure. They are even sloughed off from the surface of mucosa 7 days after the application.

This study compares the effectiveness of conventional sutures and tissue adhesives in closure of intraoral surgical wounds after removal of mandibular third molar.

Study Timeline

• Study Start: 2020-03-30
• Primary Completion: 2021-04-25
• Study Completion: 2021-04-25
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients requiring surgical removal of mesioangular, position A impacted mandibular third molar
• clean incisions approximately 2-3 cms in length which can be approximated
• Healthy (ASAI) or patients with mild systemic disease no functional limitations
• Patients not allergic to the drugs or anesthetic agents used in the surgical protocol

Exclusion Criteria

• Patients taking any medications that influences wound healing
• Patients on non steroidal anti inflammatory drugs
• smokers
• uncooperative patients patients allergic to cyanoacrylate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive	Application of cyanoacrylate tissue adhesive over the surgical wound
Group B	closure of wound using braided silk suture	Suturing the surgical wound using braided black silk

Primary Outcome Measures

Name	Time	Method
Postoperative pain	4th postoperative day	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
postoperative pain	5th postoperative day	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).
wound healing	7th postoperative day	A 5 point early wound healing scale assessing wound healing after 7 postoperative days.

Trial Locations

Locations (1)

Melaka Manipal Medical College; 🇲🇾 Melaka Tengah, Melaka, Malaysia