Clinical trial NCT03788733: The Efficacy of Melatonin in the Burning Mouth Syndrome
Official title: Study of the Efficacy of Melatonin in the Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorders, Circadian Rhythm
Keywords: Burning mouth syndrome,
melatonin
pain
sleep
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Sleep Questionnaire
timeFrame: 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
measure: Sleep Questionnaire
timeFrame: 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 outcomes:
measure: Oral Pain
timeFrame: day 0 .Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)
measure: Oral Pain
timeFrame: 8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)
measure: Questionnaire ORAL Quality of life
timeFrame: 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.
measure: Questionnaire ORAL Quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Lopez-Jornet Pia
state: N/A = Not Applicable
Study officials:
affiliation: Oral Medicine
name: Lopez-Jornet Pia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.