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The Efficacy of Melatonin in the Burning Mouth Syndrome

NCT ID: NCT03788733

Last Updated: 2018-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2019-12-14

Brief Summary

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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

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

Conditions

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Sleep Disorders, Circadian Rhythm

Keywords

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Burning mouth syndrome, melatonin pain sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Melatonin

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

Group Type EXPERIMENTAL

Melatonin 3 mg

Intervention Type DRUG

1 time a day for 8 weeks

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Oral

Intervention Type DRUG

1 time a day for 8 weeks

Interventions

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Melatonin 3 mg

1 time a day for 8 weeks

Intervention Type DRUG

Placebo Oral

1 time a day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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melatonin Placebo

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Pia Lopez Jornet

Head of Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lopez-Jornet Pia, PhD

Role: PRINCIPAL_INVESTIGATOR

Oral Medicine

Locations

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Lopez-Jornet Pia

Murcia, N/A = Not Applicable, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Lopez-Jornet Pia, PhD

Role: CONTACT

Phone: 639473308

Email: [email protected]

Facility Contacts

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Lopez-Jornet Pia

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29694465 (View on PubMed)

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.

Reference Type RESULT
PMID: 28460563 (View on PubMed)

Other Identifiers

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University Murcia

Identifier Type: -

Identifier Source: org_study_id