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

NCT ID: NCT03492814

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-10
• Study Completion Date: 2018-03-10

Brief Summary

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.

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.

Conditions

Swelling; Trismus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Partial wound closure

3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.

Group Type: EXPERIMENTAL

partial wound closure

Intervention Type: PROCEDURE

3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.

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.

Group Type: ACTIVE_COMPARATOR

total wound closure

Intervention Type: PROCEDURE

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.

Interventions

partial wound closure

3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Melaka Manipal Medical College

OTHER

Sponsor Role: lead

Responsible Party

Abdul Kalam Azad

Assistant Professor, Dept Of Oral and Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul Kalam Azad, MDS

Role: PRINCIPAL_INVESTIGATOR

Melaka Manipal Medical College

Locations

Melaka Manipal Medical College

Malacca, , Malaysia

Countries

Malaysia

Other Identifiers

MMMC/FOD/AR/B4/E C-2016(24)

Identifier Type: -

Identifier Source: org_study_id