The Efficacy of Melatonin in the Burning Mouth Syndrome

Not Applicable

• Conditions: Sleep Disorders, Circadian Rhythm
• Interventions: Drug: Melatonin 3 mg; Drug: Placebo Oral

• Registration Number: NCT03788733
• Lead Sponsor: Universidad de Murcia

Brief 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.

Detailed Description

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

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12-14
• Study First Submitted: 2018-12-22
• Study First Submitted QC: 2018-12-26
• Last Update Submitted: 2018-12-26
• Study First Posted: 2018-12-28
• Last Update Posted: 2018-12-28
• Primary Completion: 2019-06-14
• Study Completion: 2019-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin 3 mg	Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks
placebo	Placebo Oral	ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Sleep Questionnaire	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	The Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Name	Time	Method
Oral Pain	8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)	Visual Analogue Scale (VAS)
Questionnaire 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.	Questionnaire OHIP 14 Oral quality of life

Trial Locations

Locations (1)

Lopez-Jornet Pia; 🇪🇸 Murcia, N/A = Not Applicable, Spain