Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

NCT04898816 | Completed DMC

• 1 other identifier: MMMC/FOD/AR/B8/E C-2020 (08)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Application of cyanoacrylate tissue adhesive over the surgical wound

Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive

Group B

ACTIVE COMPARATOR

Suturing the surgical wound using braided black silk

Procedure: closure of wound using braided silk suture

Interventions

closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive PROCEDURE

Application of cyanoacrylate tissue adhesives over the surgical wound

Group A

closure of wound using braided silk suture PROCEDURE

suturing the surgical wound using braided black silk

Group B

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Melaka Manipal Medical College: lead

Study Sites (1)

Melaka Manipal Medical College

Melaka Tengah, Melaka, 75150, Malaysia

Location

Study Officials

• abdul K azad

  Melaka Manipal Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 24, 2021
• Study Start: March 30, 2020
• Primary Completion: April 25, 2021
• Study Completion: April 25, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 month
• Access Criteria: Study protocol will be provided only if requested through a proper channel, dean of college , with proper justification.

Locations

MY (1)