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Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

Primary Purpose

Oral Submucous Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single stage nasolabial flap
Sponsored by
Government College of Dentistry, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Submucous Fibrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    single stage nasolabial flap

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.
    Mouth opening in centimeters
    Mouth opening in centimeters
    Mouth opening in centimeters
    Mouth opening in centimeters
    Mouth opening in centimeters
    Mouth opening in centimeters
    Mouth opening in centimeters

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2016
    Last Updated
    March 12, 2016
    Sponsor
    Government College of Dentistry, Indore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02711046
    Brief Title
    Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government College of Dentistry, Indore

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    The world of medical science is replete with a plethora of conditions both physiological and pathological which exhibit manifold symptoms, some of which man has conquered while against others, he is still waging a relentless battle. In this fast changing world of stress and cut throat competition, we humans often resort ourselves to tension relieving habits like alcoholism, smoking, tobacco or betel nut chewing. Apart from the very severe systemic consequences of these habits, oral cavity is also very adversely affected. Of all the unique oral afflictions that these habits have on oral cavity of betel quid chewers, Oral Submucous Fibrosis (OSMF) holds a pivotal position. OSMF is a distressing condition in which due to limited opening of the oral cavity, the patient is neither able to consume a normal diet nor maintain proper oral hygiene. OSMF mostly occurs in Asian countries, including India ,China, Pakistan, Sri Lanka and Bangladesh, where chewing betel quid (areca nut , tobacco, slaked lime, or other species) is very popular & accepted as form of tradition in most part of these countries. It is observed that irritants like betel nuts, tobacco etc. if kept for longer period around the cheek and swallowed gradually may play a major part in the causation of the disease. In India, the first mention of this disease in literature dates back to time of 'Sushruta' as 'Vidari'. However in modern literature 'Schwartz' in 1952 first described it as "Atrophica idiopathica mucosa oris". Oral submucous fibrosis is "an insidious, chronic disease affecting any part of the oral cavity and sometimes the pharynx. Although occasionally preceded by and/or associated with vesicle formation, it is always associated with a juxta-epithelial inflammatory reaction followed by a fibroelastic change of the lamina propria, with epithelial atrophy leading to stiffness of the oral mucosa causing trismus and inability to eat" Usually in this disease patient has no disabling symptoms in the early phase, but as it progress it causes burning sensation, difficulty in eating and opening of mouth, that forces patients to report a clinician with these distressing symptoms. Sharp (1956) has described submucous fibrosis along with epithelial hyperplasia and mucosal atrophy as a characteristic feature of abnormal-precancerous oral epithelium and of tissue adjacent to frank oral cancer. OSMF can transform into oral cancer, and particularly squamous-cell carcinoma, at a rate in the range of 7% to 13%. OSMF can occur in any decade of life but is commonly seen in 2nd -4th decade of life. Various studies have suggested multifactorial origin of the disease with high incidence associated with consumption of areca nut. Reduction or preferably stoppage of the habit forms an essential component of the total treatment plan. The mainstay in the treatment of OSMF is therefore concentrated upon improving mouth opening and relieving the symptoms either by medicinal or surgical means. The medicinal treatment for mild cases of OSMF includes steroids, cardiovascular drugs, antioxidants, vitamins and iron supplements. Topical application of steroids, hyaluronidase, collagenase, and placental extract has yielded positive results in mild cases but in advanced cases, surgery followed by aggressive physiotherapy is the only viable treatment which produces satisfactory results. Excision of the fibrous bands and propping the mouth open to allow secondary epithelialisation causes rebound fibrosis during healing. Release of fibrous bands and split thickness skin grafting has a high recurrence from contracture. The survival of full thickness skin grafts is questionable. The use of island palatal flaps based on the greater palatine artery as recommended by Khanna et al. has limitations including involvement of the donor site by fibrosis, limited donor tissue with limited reach of the flap, and the need for extraction of maxillary second molars to cover the defect with the flap under no tension. The bilateral tongue flaps cause severe dysphasia, disarticulation, and carry the risk of postoperative aspiration. They also provide a limited amount of donor tissue as their reach is inadequate. The stability of a tongue flap and dehiscence are the common postoperative complications of uncontrolled tongue movements. Apart from this the reported involvement of the tongue is 38%, which precludes its use for reconstruction. Buccal fat pads may also be used to cover the defects after excision of the fibrous bands. The harvesting of the buccal fat pad is simple because access is easy. However, severe atrophy of buccal fat pads is seen in patients with chronic disease. In addition, the anterior reach of the buccal fat pad is often inadequate, and the region anterior to the cuspid is required to be left raw. This raw area heals by secondary intention and subsequently fibrosis, leading to gradual relapse. Bilateral radial forearm free flaps are hairy, 40% of patients require secondary debulking procedures, and the facilities for free tissue transfer are not universally available. Canniff and Harvey recommended temporal myotomy or coronoidectomy to release severe trismus caused by the atrophic changes in the tendon of temporalis muscle secondary to the disease. The use of the nasolabial flap in reconstruction of head and neck defects has proved to be efficacious and reliable. 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. Also the proximity to the defect and achievement of good cosmetic result with preservation of function and least distortion of anatomy makes it the flap of choice. Therefore, these advantages of 'extended single stage nasolabial flap' in the treatment of OSMF led us to carry out this study for "Evaluation of change in mouth opening in centimeters in oral submucous fibrosis patients after surgical excision of fibrous bands along with bilateral coronoidotomy & surgical defect coverage by single stage nasolabial flap". Mouth opening in centimeters was recorded pre operatively(base line),to 1 week,2 week,3 week,4 week, 2nd month,3rd month and 6 month post operatively and the change was recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Submucous Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    single stage nasolabial flap
    Arm Type
    Experimental
    Arm Description
    single staged nasolabial flap as an interpositional material after surgical resection of fibrous band in oral submucous fibrosis
    Intervention Type
    Procedure
    Intervention Name(s)
    single stage nasolabial flap
    Intervention Description
    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 Measure Information:
    Title
    Mouth opening in centimeters
    Description
    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.
    Time Frame
    Baseline
    Title
    Mouth opening in centimeters
    Time Frame
    1week
    Title
    Mouth opening in centimeters
    Time Frame
    2week
    Title
    Mouth opening in centimeters
    Time Frame
    3week
    Title
    Mouth opening in centimeters
    Time Frame
    4 week
    Title
    Mouth opening in centimeters
    Time Frame
    2 month
    Title
    Mouth opening in centimeters
    Time Frame
    3 month
    Title
    Mouth opening in centimeters
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    faisal idrees, mds
    Organizational Affiliation
    Government College of Dentistry, Indore
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    12618994
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8278485
    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.
    Results Reference
    background

    Learn more about this trial

    Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

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