Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898816
• Other study ID #: MMMC/FOD/AR/B8/E C-2020 (08)
• Status: Completed
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: April 25, 2021

Study information

• Verified date: April 2023
• Source: Melaka Manipal Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 25, 2021
• Est. primary completion date: April 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

Procedure:
• closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive
Application of cyanoacrylate tissue adhesives over the surgical wound
• closure of wound using braided silk suture
suturing the surgical wound using braided black silk

Locations

Country	Name	City	State
Malaysia	Melaka Manipal Medical College	Melaka Tengah	Melaka

Sponsors (1)

Lead Sponsor	Collaborator
Melaka Manipal Medical College

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	wound healing	A 5 point early wound healing scale assessing wound healing after 7 postoperative days.	7th postoperative day