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

NCT03492814 | Completed

• 1 other identifier: MMMC/FOD/AR/B4/E C-2016(24)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Swelling; Trismus

Keywords

impacted third molar; suturing; post-operative morbidity

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Partial wound closure

EXPERIMENTAL

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

Procedure: partial wound closure

Total wound closure

ACTIVE COMPARATOR

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

Interventions

partial wound closure PROCEDURE

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

Partial wound closure

total wound closure 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.

Total wound closure

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melaka Manipal Medical College: lead

Study Sites (1)

Melaka Manipal Medical College

Malacca, 75150, Malaysia

Location

MeSH Terms

Conditions

Trismus

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul Kalam Azad, MDS

  Melaka Manipal Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dept Of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 10, 2018
• Study Start: March 10, 2016
• Primary Completion: March 10, 2018
• Study Completion: March 10, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

MY (1)