The Efficacy of Melatonin in the Burning Mouth Syndrome (BMS)

Universidad de Murcia

Status: Unknown

Conditions: Sleep Disorders, Circadian Rhythm

Treatments: Drug: Placebo Oral; Drug: Melatonin 3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03788733

University Murcia

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks

Treatment:

Drug: Melatonin 3 mg

placebo

Placebo Comparator group

Description:

ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks

Treatment:

Drug: Placebo Oral