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Oral Submucous FibrosisNCT02711046

Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

A study testing single stage nasolabial flap in people with Oral Submucous Fibrosis, run by Government College of Dentistry, Indore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Oral Submucous Fibrosis
What is being tested?
single stage nasolabial flap
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
No sites listed yet
Study dates
Mar 2011to Sep 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the 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.

Being tested
single stage nasolabial flap
Medical subject headings
Oral Submucous Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single stage nasolabial flapProcedure or surgery

    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.

Study groups in NCT02711046
Study groupRoleWhat they receive
single stage nasolabial flapExperimentalsingle staged nasolabial flap as an interpositional material after surgical resection of fibrous band in oral submucous fibrosis
Receives: Procedure: single stage nasolabial flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. Mouth opening in centimeters

    Measured: 1week

  3. Mouth opening in centimeters

    Measured: 2week

  4. Mouth opening in centimeters

    Measured: 3week

  5. Mouth opening in centimeters

    Measured: 4 week

  6. Mouth opening in centimeters

    Measured: 2 month

  7. Mouth opening in centimeters

    Measured: 3 month

  8. Mouth opening in centimeters

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2016 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2011
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02711046
Sponsor's protocol ID
GDCORALSURGERY
Status last verified
Mar 2016
First submitted
16 Feb 2016
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 12618994
  • 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.

    PubMed 8278485

Questions about this trial

What is this clinical trial studying?

A study testing single stage nasolabial flap in people with Oral Submucous Fibrosis, run by Government College of Dentistry, Indore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mouth opening in centimeters (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02711046, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.

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