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Interventions for the management of oral submucous fibrosis

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Abstract

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Background

Oral submucous fibrosis (OSF) is a chronic disease of the oral cavity which is more commonly found in patients in the Asian subcontinent and the Far East. It is characterised by the progressive build up of constricting bands of collagen in the cheeks and adjacent structures of the mouth which can severely restrict mouth opening and tongue movement and cause problems with speech and swallowing.

Objectives

To assess the effectiveness of interventions for the management of pain and restricted jaw opening or movement occurring as a result of oral submucous fibrosis.

Search methods

We searched the Cochrane Oral Health Group's Trials Register to July 2008; CENTRAL (The Cochrane Library 2008, Issue 2); MEDLINE (from 1950 to July 2008); EMBASE (from 1980 to July 2008) and IndMED on 18th November 2007. There were no language restrictions.

Selection criteria

Randomised controlled trials comparing surgical interventions, systemic or topical medicines or other interventions to manage the symptoms of oral submucous fibrosis.

Data collection and analysis

Two authors independently assessed trial quality and extracted trial data. Disagreements were resolved by consultation with a third author. Attempts were made to contact study authors where necessary for clarification and for additional information.

Main results

Two trials, involving 87 participants, evaluated lycopene in conjunction with intralesional injections of a steroid, and pentoxifylline in combination with mouth stretching exercises and heat. Only two of the primary but none of the secondary outcomes of this review were considered in these trials and provided a limited amount of unreliable data. The data in one trial were based on inadequately defined evaluations of outcomes, and in the other trial are likely to be skewed due to a substantial number of withdrawals and therefore were not entered into the RevMan analyses. There were no reports of toxicity to the interventions but some side effects, which were mostly gastric irritation to pentoxifylline, were noted.

Authors' conclusions

The lack of reliable evidence for the effectiveness of any specific interventions for the management of oral submucous fibrosis is illustrated by the paucity, and poor methodological quality, of trials retrieved for this review.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

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Interventions for the management of oral submucous fibrosis

Oral submucous fibrosis is a chronic disease which is commonly found in patients in the Asian subcontinent and the Far East and is characterised by the build up of constricting bands of collagen in the cheeks and adjacent structures of the mouth. The precise cause is unknown but chewing of betel quid as well as other areca nut containing products, excessive use of chillies and spices, poor nutrition and vitamin and iron deficiency have been suggested.

Mucosal ulcers may occur at an earlier stage, whereas fibrous bands in the cheeks and lips, depigmented gums and a rubbery and deformed soft palate and blanched, leathery floor of the mouth are later developments. These changes can severely restrict mouth opening and tongue movement and cause problems with speech and swallowing whilst other symptoms include a burning sensation whilst eating spicy food, dry mouth and hearing loss.

Treatment options include iron and multivitamin supplements including lycopene, an extract of tomato, and a range of medicines (e.g. intralesional injection of steroids, hyaluronidase, human placenta extracts, chemotrypsin, pentoxifylline and collagenase). Surgery, including cutting of the fibrous bands and jaw muscles and joint, has been used for more extreme cases.

The review authors found two studies which evaluated the effectiveness of lycopene in conjunction with intralesional injections of a steroid, and pentoxifylline in combination with mouth stretching exercises and heat. These studies provided a limited amount of unreliable data which did not permit any firm conclusions to be made. There were no reports of toxicity but some side effects, which were mostly gastric irritation to pentoxifylline, were noted.

Future research should aim to provide evidence for people to make informed decisions about whether these treatments are effective and should also explore treatment plans which include patient education aimed at cessation of the chewing habit.