Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

Sponsor

Melaka Manipal Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT04898816

Collaborator

(none)

Enrollment

Location

Arms

12.8

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Heal	Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive Procedure: closure of wound using braided silk suture	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 30, 2020

Actual Primary Completion Date :

Apr 25, 2021

Actual Study Completion Date :

Apr 25, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative pain [5th postoperative day]
A 10 mm Numerical rating scale assessing pain on the 5th postoperative day. 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. Possible score ranges from 1(complete flap closure without fibrin line) to 5 (incomplete flap closure with necrosis)

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Melaka Manipal Medical College	Melaka Tengah	Melaka	Malaysia	75150

Sponsors and Collaborators

Melaka Manipal Medical College

Investigators

Principal Investigator: abdul K azad, Melaka Manipal Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdul Kalam Azad, Assistant Professor, Melaka Manipal Medical College

ClinicalTrials.gov Identifier:

NCT04898816

Other Study ID Numbers:

MMMC/FOD/AR/B8/E C-2020 (08)

First Posted:

May 24, 2021

Last Update Posted:

May 24, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 24, 2021