Oral Submucous Fibrosis Clinical Trial
Official title:
Evaluation of Change in Mouth Opening in Oral Submucous Fibrosis Patients After Surgical Excision of Fibrous Bands Along With Bilateral Coronoidotomy and Surgical Defect Coverage by Single Stage Extended Nasolabial Flap
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 |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Histologically confirmed cases of OSMF based on thorough clinical examination and long standing positive history of habits such as chewing betel nut etc. - Decreased mouth opening (less or equal to 25mm interincisal distance). - Patients willing to quit habit. - Intra orally palpable fibrous bands. Exclusion Criteria: - Mouth opening > 25 mm. - Patients showing malignant changes in histopathological report. - Medically compromised patients unfit for surgery under general anesthesia. - Patients not willing to quit habit. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Government College of Dentistry, Indore |
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
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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