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

Primary Purpose

Swelling, Trismus

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
partial wound closure
total wound closure
Sponsored by
Melaka Manipal Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Swelling focused on measuring impacted third molar, suturing, post-operative morbidity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Melaka Manipal Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Partial wound closure

Total wound closure

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
postoperative swelling
three line measurements were performed in cm using a measuring tape and mean was taken

Secondary Outcome Measures

Full Information

First Posted
April 1, 2018
Last Updated
April 9, 2018
Sponsor
Melaka Manipal Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03492814
Brief Title
Comparing Different Suturing Techniques on the Post-operative Morbidity After Removal of Impacted Mandibular Third Molar
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
March 10, 2018 (Actual)
Study Completion Date
March 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Melaka Manipal Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swelling, Trismus
Keywords
impacted third molar, suturing, post-operative morbidity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partial wound closure
Arm Type
Experimental
Arm Description
3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.
Arm Title
Total wound closure
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
partial wound closure
Intervention Description
3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.
Intervention Type
Procedure
Intervention Name(s)
total wound closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in the Measurement of mouth opening
Description
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.
Time Frame
baseline( preoperative) and 3rd and 7th day postoperatively.
Title
postoperative swelling
Description
three line measurements were performed in cm using a measuring tape and mean was taken
Time Frame
baseline ( preoperative) and 3rd and 7th day postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Kalam Azad, MDS
Organizational Affiliation
Melaka Manipal Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melaka Manipal Medical College
City
Melaka
ZIP/Postal Code
75150
Country
Malaysia

12. IPD Sharing Statement

Learn more about this trial

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

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