The Efficacy of Melatonin in the Burning Mouth Syndrome (BMS)

Study of the Efficacy of Melatonin in the Burning Mouth Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: Drug: Melatonin 3 mg; Drug: Placebo Oral

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lopez-Jornet Pia, PhD; Phone Number: 639473308; Email: majornet@um.es

Study Locations

• Spain
  • N/A = Not Applicable
    • Murcia, N/A = Not Applicable, Spain, 30008
      • Recruiting
      • Lopez-Jornet Pia
      • Contact: Lopez-Jornet Pia; Phone Number: 639473308; Email: majornet@um.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin; Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks	Drug: Melatonin 3 mg; 1 time a day for 8 weeks; Other Names: melatonin
Placebo Comparator: placebo; ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks	Drug: Placebo Oral; 1 time a day for 8 weeks; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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.
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.

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Investigators: Principal Investigator: Lopez-Jornet Pia, PhD, Oral Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Anticipated): June 14, 2019
• Study Completion (Anticipated): December 14, 2019

Study Registration Dates

• First Submitted: December 22, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pain; sleep; melatonin; Burning mouth syndrome,
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Wounds and Injuries; Stomatognathic Diseases; Mouth Diseases; Occupational Diseases; Chronobiology Disorders; Burns; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Burning Mouth Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: University Murcia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No