The Efficacy of Melatonin in the Burning Mouth Syndrome

NCT03788733 | Unknown

• 1 other identifier: University Murcia
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders, Circadian Rhythm

Keywords

Burning mouth syndrome,; melatonin; pain; sleep

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Oral Pain

  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

  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

  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

  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.

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks

Drug: Melatonin 3 mg

placebo

PLACEBO COMPARATOR

ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks

Drug: Placebo Oral

Interventions

Melatonin 3 mg DRUG

1 time a day for 8 weeks

Also known as: melatonin

Melatonin

Placebo Oral DRUG

1 time a day for 8 weeks

Also known as: Placebo

placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions

You may not qualify if:

• Previous or current therapy with melatonin
• Allergy or hypersensitivity to melatonin
• Less than 18 years old.
• Pregnant

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Lopez-Jornet Pia

Murcia, N/A = Not Applicable, 30008, Spain

RECRUITING

Related 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.

  PMID: 29694465 BACKGROUND

• 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.

  PMID: 28460563 RESULT

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Burning Mouth Syndrome; Pain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lopez-Jornet Pia, PhD

  Oral Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lopez-Jornet Pia, PhD

CONTACT

639473308; majornet@um.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oral Medicine

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: December 28, 2018
• Study Start: December 14, 2018
• Primary Completion: June 14, 2019
• Study Completion: December 14, 2019
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)