The Efficacy of Melatonin in the Burning Mouth Syndrome

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StatusRekrutierung

Sponsoren

Universidad de Murcia

KLINISCHE STUDIE: NCT03788733

BioSeek: NCT03788733

Schlüsselwörter

Abstrakt

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.

Beschreibung

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

Termine

Zuletzt überprüft:	11/30/2018
Zuerst eingereicht:	12/21/2018
Geschätzte Einschreibung eingereicht:	12/25/2018
Zuerst veröffentlicht:	12/27/2018
Letztes eingereichtes Update:	12/25/2018
Letztes Update veröffentlicht:	12/27/2018
Tatsächliches Startdatum der Studie:	12/13/2018
Geschätztes primäres Abschlussdatum:	06/13/2019
Voraussichtliches Abschlussdatum der Studie:	12/13/2019

Zustand oder Krankheit

Sleep Disorders, Circadian Rhythm

Intervention / Behandlung

Drug: Melatonin

Drug: placebo

Phase

Armgruppen

Arm	Intervention / Behandlung
Experimental: Melatonin Melatonin ORAL FILM 3mg will be taken by the subject once a day for 8 weeks	Drug: Melatonin 1 time a day for 8 weeks
Placebo Comparator: placebo ORAL FILM 3mg placebo will be taken by the subject once a day for 8 weeks	Drug: placebo 1 time a day for 8 weeks

Zulassungskriterien

Studienberechtigte Geschlechter

All

Akzeptiert gesunde Freiwillige

Kriterien

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

Ergebnis

Primäre Ergebnismaße

1. Sleep Questionnaire [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)

2. Sleep Questionnaire [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)

Sekundäre Ergebnismaße

1. 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)]

Visual Analogue Scale (VAS)

2. 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)]

Visual Analogue Scale (VAS)

3. 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 OHIP 14 Oral quality of life

4. 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.]