Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-20 @ 3:46 PM
Study NCT ID:
NCT03788733
Status:
UNKNOWN
Last Update Posted:
2018-12-28
First Post:
2018-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Melatonin in the Burning Mouth Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}, {'id': 'D002054', 'term': 'Burning Mouth Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-26', 'studyFirstSubmitDate': '2018-12-22', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Questionnaire', 'timeFrame': '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', 'description': 'The Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Sleep Questionnaire', 'timeFrame': '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', 'description': 'The Pittsburgh Sleep Quality Index (PSQI)'}], 'secondaryOutcomes': [{'measure': 'Oral Pain', 'timeFrame': 'day 0 .Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)', 'description': 'Visual Analogue Scale (VAS)'}, {'measure': 'Oral Pain', 'timeFrame': '8 weeks.Pain was scored using a Visual Analogue Scale (VAS) (with a score of 1-10: 0 = no pain, 10 = extreme pain)', 'description': 'Visual Analogue Scale (VAS)'}, {'measure': 'Questionnaire ORAL Quality of life', 'timeFrame': '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.', 'description': 'Questionnaire OHIP 14 Oral quality of life'}, {'measure': 'Questionnaire ORAL Quality of life', 'timeFrame': '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.', 'description': 'Questionnaire OHIP 14 Oral quality of life'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burning mouth syndrome,', 'melatonin', 'pain', 'sleep'], 'conditions': ['Sleep Disorders, Circadian Rhythm']}, 'referencesModule': {'references': [{'pmid': '29694465', 'type': 'BACKGROUND', 'citation': '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': '28460563', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nA 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.", 'detailedDescription': 'The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions\n\nExclusion Criteria:\n\n* Previous or current therapy with melatonin\n* Allergy or hypersensitivity to melatonin\n* Less than 18 years old.\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03788733', 'acronym': 'BMS', 'briefTitle': 'The Efficacy of Melatonin in the Burning Mouth Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Study of the Efficacy of Melatonin in the Burning Mouth Syndrome', 'orgStudyIdInfo': {'id': 'University Murcia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin', 'description': 'Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks', 'interventionNames': ['Drug: Melatonin 3 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks', 'interventionNames': ['Drug: Placebo Oral']}], 'interventions': [{'name': 'Melatonin 3 mg', 'type': 'DRUG', 'otherNames': ['melatonin'], 'description': '1 time a day for 8 weeks', 'armGroupLabels': ['Melatonin']}, {'name': 'Placebo Oral', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '1 time a day for 8 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30008', 'city': 'Murcia', 'state': 'N/A = Not Applicable', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lopez-Jornet Pia', 'role': 'CONTACT', 'email': 'majornet@um.es', 'phone': '639473308'}], 'facility': 'Lopez-Jornet Pia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Lopez-Jornet Pia, PhD', 'role': 'CONTACT', 'email': 'majornet@um.es', 'phone': '639473308'}], 'overallOfficials': [{'name': 'Lopez-Jornet Pia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oral Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Oral Medicine', 'investigatorFullName': 'Pia Lopez Jornet', 'investigatorAffiliation': 'Universidad de Murcia'}}}}