Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound Heal

Intervention / Treatment
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* Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive
* Procedure: closure of wound using braided silk suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Application of cyanoacrylate tissue adhesive over the surgical wound | Procedure: closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive<br>* Application of cyanoacrylate tissue adhesives over the surgical wound<br>|
| Active Comparator: Group B<br>Suturing the surgical wound using braided black silk | Procedure: closure of wound using braided silk suture<br>* suturing the surgical wound using braided black silk<br>|

What is the study measuring?
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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 |