The Efficacy of Melatonin in the Burning Mouth Syndrome (BMS)
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ClinicalTrials.gov Identifier: NCT03788733 |
Recruitment Status : Unknown
Verified December 2018 by Pia Lopez Jornet, Universidad de Murcia.
Recruitment status was: Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Disorders, Circadian Rhythm | Drug: Melatonin 3 mg Drug: Placebo Oral | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Study of the Efficacy of Melatonin in the Burning Mouth Syndrome |
Actual Study Start Date : | December 14, 2018 |
Estimated Primary Completion Date : | June 14, 2019 |
Estimated Study Completion Date : | December 14, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Melatonin
Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks
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Drug: Melatonin 3 mg
1 time a day for 8 weeks
Other Name: 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 Name: Placebo |
- Sleep Questionnaire [ Time Frame: 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 ]The Pittsburgh Sleep Quality Index (PSQI)
- Sleep Questionnaire [ Time Frame: 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 ]The Pittsburgh Sleep Quality Index (PSQI)
- Oral Pain [ Time Frame: day 0 .Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain) ]Visual Analogue Scale (VAS)
- Oral Pain [ Time Frame: 8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain) ]Visual Analogue Scale (VAS)
- Questionnaire ORAL Quality of life [ Time Frame: 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 OHIP 14 Oral quality of life
- Questionnaire ORAL Quality of life [ Time Frame: 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. ]Questionnaire OHIP 14 Oral quality of life

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788733
Contact: Lopez-Jornet Pia, PhD | 639473308 | majornet@um.es |
Spain | |
Lopez-Jornet Pia | Recruiting |
Murcia, N/A = Not Applicable, Spain, 30008 | |
Contact: Lopez-Jornet Pia 639473308 majornet@um.es |
Principal Investigator: | Lopez-Jornet Pia, PhD | Oral Medicine |
Other Publications:
Responsible Party: | Pia Lopez Jornet, Head of Oral Medicine, Universidad de Murcia |
ClinicalTrials.gov Identifier: | NCT03788733 |
Other Study ID Numbers: |
University Murcia |
First Posted: | December 28, 2018 Key Record Dates |
Last Update Posted: | December 28, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Burning mouth syndrome, melatonin pain sleep |
Burning Mouth Syndrome Sleep Wake Disorders Sleep Disorders, Circadian Rhythm Burns Nervous System Diseases Neurologic Manifestations Mental Disorders Wounds and Injuries Mouth Diseases Stomatognathic Diseases |
Chronobiology Disorders Dyssomnias Occupational Diseases Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |