NCT03788733: BMS

The Efficacy of Melatonin in the Burning Mouth Syndrome

Status unknown NA Last updated 28 December 2018

What this trial tests

NA trial testing Melatonin 3 mg in Sleep Disorders, Circadian Rhythm in 80 participants. Status unknown.

Timeline

14 December 2018

Primary endpoint
14 June 2019

14 December 2019

Quick facts

Lead sponsor	Universidad de Murcia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	14 December 2018
Primary completion	14 June 2019
Estimated completion	14 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Melatonin 3 mg — full drug profile →
• Placebo Oral

Conditions studied

• Sleep Disorders, Circadian Rhythm — all drugs for Sleep Disorders, Circadian Rhythm →

Sponsor

Universidad de Murcia — full company profile →

Who can join

Eligibility, any sex, with Sleep Disorders, Circadian Rhythm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome.
   Castillo-Felipe C, Tvarijonaviciute A, López-Arjona M, Pardo-Marin L, et al · · 2022 · cited 12× · PMID 35566642 · DOI 10.3390/jcm11092516