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Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02711046
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
Dr. Faisal Idrees, Government College of Dentistry, Indore

Brief 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.

Condition or disease Intervention/treatment Phase
Oral Submucous Fibrosis Procedure: single stage nasolabial flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: single stage nasolabial flap
single staged nasolabial flap as an interpositional material after surgical resection of fibrous band in oral submucous fibrosis
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.

Primary Outcome Measures :
  1. Mouth opening in centimeters [ Time Frame: Baseline ]
    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.

  2. Mouth opening in centimeters [ Time Frame: 1week ]
  3. Mouth opening in centimeters [ Time Frame: 2week ]
  4. Mouth opening in centimeters [ Time Frame: 3week ]
  5. Mouth opening in centimeters [ Time Frame: 4 week ]
  6. Mouth opening in centimeters [ Time Frame: 2 month ]
  7. Mouth opening in centimeters [ Time Frame: 3 month ]
  8. Mouth opening in centimeters [ Time Frame: 6 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02711046

Sponsors and Collaborators
Government College of Dentistry, Indore
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Principal Investigator: faisal idrees, mds Government College of Dentistry, Indore

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Responsible Party: Dr. Faisal Idrees, Dr., Government College of Dentistry, Indore Identifier: NCT02711046    
Other Study ID Numbers: GDCORALSURGERY
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Oral Submucous Fibrosis
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases