Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures in the Closure of Intraoral Surgical Wounds- A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive; Procedure: closure of wound using braided silk suture

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Melaka
    • Melaka Tengah, Melaka, Malaysia, 75150
      • Melaka Manipal Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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: Group A; Application of cyanoacrylate tissue adhesive over the surgical wound	Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive; Application of cyanoacrylate tissue adhesives over the surgical wound
Active Comparator: Group B; Suturing the surgical wound using braided black silk	Procedure: closure of wound using braided silk suture; suturing the surgical wound using braided black silk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).	1st postoperative day
postoperative pain	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).	2nd postoperative day
Postoperative pain	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).	3rd postoperative day
Postoperative pain	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).	4th postoperative day
postoperative pain	A 10 mm Numerical rating scale assessing postoperative pain. Possible score ranges from 0 (no pain) to 10 (worst possible pain).	5th postoperative day
wound healing	A 5 point early wound healing scale assessing wound healing after 7 postoperative days.	7th postoperative day

Collaborators and Investigators

• Sponsor: Melaka Manipal Medical College
• Investigators: Principal Investigator: Abdul K Azad, Melaka Manipal Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): April 25, 2021
• Study Completion (Actual): April 25, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MMMC/FOD/AR/B8/E C-2020 (08)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 month
• IPD Sharing Access Criteria: Study protocol will be provided only if requested through a proper channel, dean of college , with proper justification.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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