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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
- Conditions
- Oral Submucous Fibrosis
- 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 group | Role | What they receive |
|---|---|---|
| single stage nasolabial flap | Experimental | single 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.
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
Mouth opening in centimeters
Measured: 1week
Mouth opening in centimeters
Measured: 2week
Mouth opening in centimeters
Measured: 3week
Mouth opening in centimeters
Measured: 4 week
Mouth opening in centimeters
Measured: 2 month
Mouth opening in centimeters
Measured: 3 month
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.
- First posted17 Mar 2016 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral Submucous FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Faisal Idrees, Government College of Dentistry, Indore
- Investigators
- faisal idrees, mds, Principal investigator, Government College of Dentistry, Indore
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 12618994Yousif 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02711046
- Acronym / sponsor ID
- GDCORALSURGERY
- Conditions
- Oral Submucous Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single stage nasolabial flap | Experimental | Procedure: single stage nasolabial flapsingle staged nasolabial flap as an interpositional material after surgical resection of fibrous band in oral submucous fibrosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single stage nasolabial flapThe 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. | Procedure or surgery | single stage nasolabial flap |
Primary outcome
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.
Mouth opening in centimeters
Time frame: 1week
Mouth opening in centimeters
Time frame: 2week
Mouth opening in centimeters
Time frame: 3week
Mouth opening in centimeters
Time frame: 4 week
Mouth opening in centimeters
Time frame: 2 month
Mouth opening in centimeters
Time frame: 3 month
Mouth opening in centimeters
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Background: PubMed 12618994Lazaridis 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.
- Background: PubMed 8278485Yousif 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
faisal idrees, mds principal investigator
Government College of Dentistry, Indore
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.