The Efficacy of Melatonin in the Burning Mouth Syndrome

Study Overview
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Brief Summary
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Burning mouth ( BMS) syndrome is the oral disorder characterized by an intraoral burning sensation for which no medical or dental cause can be found. The Headache Classification Committee of the International Headache Society (IHS) defines (BMS) as an ''intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions''. (BMS) is a common, chronic problem that has a negative impact on quality of life. A wide variety of medications have been proposed for treating (BMS) both topical and systemic. Unfortunately, no treatment seems to offer assured results. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep Melatonin also may help sleep disturbances associated with (BMS) ; however, this remains to be proven.

Detailed Description
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The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)

Official Title
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Study of the Efficacy of Melatonin in the Burning Mouth Syndrome

Conditions
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Sleep Disorders, Circadian Rhythm

Intervention / Treatment
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* Drug: Melatonin 3 mg
* Drug: Placebo Oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions Exclusion Criteria: Previous or current therapy with melatonin Allergy or hypersensitivity to melatonin Less than 18 years old. Pregnant
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks | Drug: Melatonin 3 mg<br>* 1 time a day for 8 weeks<br>* Other names: melatonin;|
| Placebo Comparator: placebo<br>ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks | Drug: Placebo Oral<br>* 1 time a day for 8 weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Questionnaire | The Pittsburgh Sleep Quality Index (PSQI) | day 0 .The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 8 weeks of treatment. A negative score means that the sleep | 
| Sleep Questionnaire | The Pittsburgh Sleep Quality Index (PSQI) | 8 weeks.The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 8 weeks of treatment. A negative score means that the sleep | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Pain | Visual Analogue Scale (VAS) | day 0 .Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain) | 
| Oral Pain | Visual Analogue Scale (VAS) | 8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain) | 
| Questionnaire ORAL Quality of life | Questionnaire OHIP 14 Oral quality of life | day 0 The instrument consists of 14 items that explore different aspects of oral function and quality of life. The score ranges from 0 to 70, with higher scores corresponding to poorer oral quality of life. | 
| Questionnaire ORAL Quality of life | Questionnaire OHIP 14 Oral quality of life | 8 weeks The instrument consists of 14 items that explore different aspects of oral function and quality of life. The score ranges from 0 to 70, with higher scores corresponding to poorer oral quality of life. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burning mouth syndrome,, melatonin, pain, sleep