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The Efficacy of Melatonin in the Burning Mouth Syndrome

NCT03788733 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-12-28

No results posted yet for this 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.

Conditions

  • Sleep Disorders, Circadian Rhythm

Interventions

DRUG

Melatonin 3 mg

1 time a day for 8 weeks

DRUG

Placebo Oral

1 time a day for 8 weeks

Sponsors & Collaborators

  • Universidad de Murcia

    lead OTHER

Principal Investigators

  • Lopez-Jornet Pia, PhD · Oral Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2019-06-14
Completion
2019-12-14

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788733 on ClinicalTrials.gov