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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03492814
Other study ID # MMMC/FOD/AR/B4/E C-2016(24)
Secondary ID
Status Completed
Phase N/A
First received April 1, 2018
Last updated April 9, 2018
Start date March 10, 2016
Est. completion date March 10, 2018

Study information

Verified date April 2018
Source Melaka Manipal Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 10, 2018
Est. primary completion date March 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
partial wound closure
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.

Locations

Country Name City State
Malaysia Melaka Manipal Medical College Melaka

Sponsors (1)

Lead Sponsor Collaborator
Melaka Manipal Medical College

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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