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

Sponsor

Melaka Manipal Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT03492814

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Swelling Trismus	Procedure: partial wound closure Procedure: total wound closure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 10, 2016

Actual Primary Completion Date :

Mar 10, 2018

Actual Study Completion Date :

Mar 10, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

change in the Measurement of mouth opening [baseline( preoperative) and 3rd and 7th day postoperatively.]
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.
postoperative swelling [baseline ( preoperative) and 3rd and 7th day postoperatively.]
three line measurements were performed in cm using a measuring tape and mean was taken

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Melaka Manipal Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdul Kalam Azad, Assistant Professor, Dept Of Oral and Maxillofacial Surgery, Melaka Manipal Medical College

ClinicalTrials.gov Identifier:

NCT03492814

Other Study ID Numbers:

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

First Posted:

Apr 10, 2018

Last Update Posted:

Apr 10, 2018

Last Verified:

Apr 1, 2018

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

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

Keywords provided by Abdul Kalam Azad, Assistant Professor, Dept Of Oral and Maxillofacial Surgery, Melaka Manipal Medical College

impacted third molar

suturing

post-operative morbidity

Additional relevant MeSH terms:

Tooth, Impacted

Trismus

Study Results

No Results Posted as of Apr 10, 2018