Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

NCT02711046 | Completed DMC

• 1 other identifier: GDCORALSURGERY
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Submucous Fibrosis

Outcome Measures

Primary Outcomes (8)

• 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

• Mouth opening in centimeters

  1week

• Mouth opening in centimeters

  2week

• Mouth opening in centimeters

  3week

• Mouth opening in centimeters

  4 week

• Mouth opening in centimeters

  2 month

• Mouth opening in centimeters

  3 month

• Mouth opening in centimeters

  6 month

Study Arms (1)

single stage nasolabial flap

EXPERIMENTAL

single staged nasolabial flap as an interpositional material after surgical resection of fibrous band in oral submucous fibrosis

Procedure: single stage nasolabial flap

Interventions

single stage nasolabial flap PROCEDURE

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.

single stage nasolabial flap

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government College of Dentistry, Indore: lead

Related 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. doi: 10.1053/joms.2003.50045.

  PMID: 12618994 BACKGROUND

• 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.

  PMID: 8278485 BACKGROUND

MeSH Terms

Conditions

Oral Submucous Fibrosis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• faisal idrees, mds

  Government College of Dentistry, Indore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 17, 2016
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: March 17, 2016

Record last verified: 2016-03