CompletedNot Applicable

Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

11 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mouth opening in centimeters

Timeframe: Baseline

Mouth opening in centimeters

Timeframe: 1week

Mouth opening in centimeters

Timeframe: 2week

Mouth opening in centimeters

Timeframe: 3week

Mouth opening in centimeters

Timeframe: 4 week

Mouth opening in centimeters

Timeframe: 2 month

Mouth opening in centimeters

Timeframe: 3 month

Mouth opening in centimeters

Timeframe: 6 month

Trial details

NCT IDNCT02711046

SponsorGovernment College of Dentistry, Indore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

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