The Efficacy of Melatonin in the Burning Mouth Syndrome

Last updated: December 26, 2018
Sponsor: Universidad de Murcia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Oral Facial Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT03788733
University Murcia
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours perday over more than 3 months, without clinically evident causative lesions

Exclusion

Exclusion Criteria:

  • Previous or current therapy with melatonin

  • Allergy or hypersensitivity to melatonin

  • Less than 18 years old.

  • Pregnant

Study Design

Total Participants: 80
Study Start date:
December 14, 2018
Estimated Completion Date:
December 14, 2019

Study Description

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

Connect with a study center

  • Lopez-Jornet Pia

    Murcia, N/A = Not Applicable 30008
    Spain

    Active - Recruiting

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