Comparing Different Suturing Techniques on the Post-operative Morbidity After Removal of Impacted Mandibular Third Molar

Comparing the Effect of Different Suture Techniques on the Post Operative Morbidity After Surgical Removal of Impacted Mandibular Third Molar- A Randomized Clinical Study

This study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group.

Study Overview

• Status: Completed
• Conditions: Trismus; Swelling
• Intervention / Treatment: Procedure: partial wound closure; Procedure: total wound closure

Detailed Description

Third molar surgeries are mostly associated with pain, swelling and limited mouth opening, referred to as post-operative morbidity. Wound closure technique is an operative factor which is associated with reduced post-operative morbidity. In the total wound closure, the mucoperiosteum is hermetically sealed whereas in the partial wound closure, a window or opening is left to allow for secondary healing. This study therefore compares the effect of partial and total wound closure techniques after surgical extraction of impacted mandibular third molar teeth in reducing the swelling and limited mouth opening.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients undergoing surgical removal of mesioangular impacted mandibular third molar.
• Healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II).
• patients who are not allergic to the drugs and local anesthetic agent used in the surgical protocol.

Exclusion Criteria:

• Patients having systemic conditions that might have an effect on the bone growth or periodontal healing.
• patients who are on antibiotics premedication or any drugs that might affect wound healing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial wound closure; 3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.	Procedure: partial wound closure; 3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.
Active Comparator: Total wound closure; 5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound.	Procedure: total wound closure; 5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the Measurement of mouth opening	mouth opening is measure by measuring the maximum interincisal distance from the incisal edge of maxillary right central incisor to the incisal edge of the lower right central incisor using a vernier calliper in mm.	baseline( preoperative) and 3rd and 7th day postoperatively.
postoperative swelling	three line measurements were performed in cm using a measuring tape and mean was taken	baseline ( preoperative) and 3rd and 7th day postoperatively.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2016
• Primary Completion (Actual): March 10, 2018
• Study Completion (Actual): March 10, 2018

Study Registration Dates

• First Submitted: April 1, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: impacted third molar; suturing; post-operative morbidity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Stomatognathic Diseases; Neuromuscular Manifestations; Tooth Diseases; Spasm; Tooth, Impacted; Trismus
• Other Study ID Numbers: MMMC/FOD/AR/B4/E C-2016(24)

Drug and device information, study documents

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