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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02711046
Other study ID # GDCORALSURGERY
Secondary ID
Status Completed
Phase N/A
First received February 16, 2016
Last updated March 12, 2016
Start date March 2011
Est. completion date September 2012

Study information

Verified date March 2016
Source Government College of Dentistry, Indore
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Long standing oral submucous fibrosis(OSMF) is associated with involvement

of the oral submucosa and the muscles of mastication leading to difficulty in mouth

opening. Various surgical modalities are mentioned for release but each has its own limitations.The aim of the study was to evaluate the change in mouth opening in patients of OSMF after excision of fibrous bands followed by coronoidotomy and surgical defect coverage by single stage nasolabial flap.


Description:

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Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
single stage nasolabial flap
The versatility of this flap has been attributed to the fact that there is often abundant non-hair-bearing skin in this well-vascularized region. The facial and infraorbital arteries are frequently cited in anatomic descriptions of the nasolabial flap. The venous drainage is believed to be via the angular and facial veins.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Government College of Dentistry, Indore

References & Publications (2)

Lazaridis N. Unilateral subcutaneous pedicled nasolabial island flap for anterior mouth floor reconstruction. J Oral Maxillofac Surg. 2003 Feb;61(2):182-90. — View Citation

Yousif NJ, Gosain A, Matloub HS, Sanger JR, Madiedo G, Larson DL. The nasolabial fold: an anatomic and histologic reappraisal. Plast Reconstr Surg. 1994 Jan;93(1):60-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mouth opening in centimeters comparison of pre operative,intra operative,1 week post operative , 2nd week, 3rd week,4th week, 2nd month,3rd month, 6th month post operative mouth opening. Baseline No
Primary Mouth opening in centimeters 1week No
Primary Mouth opening in centimeters 2week No
Primary Mouth opening in centimeters 3week No
Primary Mouth opening in centimeters 4 week No
Primary Mouth opening in centimeters 2 month No
Primary Mouth opening in centimeters 3 month No
Primary Mouth opening in centimeters 6 month No
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