The Efficacy of Melatonin in the Burning Mouth Syndrome

Sleep Disorders, Circadian Rhythm Clinical Trial

— BMS  

Official title:

Study of the Efficacy of Melatonin in the Burning Mouth Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788733
• Other study ID #: University Murcia
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: December 14, 2019

Study information

• Verified date: December 2018
• Source: Universidad de Murcia
• Contact: Lopez-Jornet Pia, PhD
• Phone: 639473308
• Email: majornet[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Drug:
• Melatonin 3 mg
1 time a day for 8 weeks
• Placebo Oral
1 time a day for 8 weeks

Locations

Country	Name	City	State
Spain	Lopez-Jornet Pia	Murcia	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Varoni EM, Lo Faro AF, Lodi G, Carrassi A, Iriti M, Sardella A. Melatonin Treatment in Patients with Burning Mouth Syndrome: A Triple-Blind, Placebo-Controlled, Crossover Randomized Clinical Trial. J Oral Facial Pain Headache. 2018 Spring;32(2):178-188. doi: 10.11607/ofph.1913. — View Citation

Xie Z, Chen F, Li WA, Geng X, Li C, Meng X, Feng Y, Liu W, Yu F. A review of sleep disorders and melatonin. Neurol Res. 2017 Jun;39(6):559-565. doi: 10.1080/01616412.2017.1315864. Epub 2017 May 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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.
Secondary	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.