Burning Mouth SyndromeNCT05309681
Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome
An observational study of Burning Mouth Syndrome and Melatonin, run by University of Zagreb at 1 site in Croatia.
Trial summary
Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Burning Mouth Syndrome, Melatonin
- What is being tested?
- Epworth's sleepiness scale; unstimulated saliva sample
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteCroatia
- Study dates
- 7 Jan 2021to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: Female patients with burning mouth syndrome and age-matched female controls without burning mouth syndrome or oral lesions will be included in the study. A sample of unstimulated saliva will be taken from all patients and frozen. All patients will also fill in Epworth's sleepiness scale.
Who may be able to join
- female patients
- primary burning mouth syndrome
- without oral lesions
Who cannot join
- secondary burning mouth syndrome
- male gender
- patients with oral lesions
Trial locations and contacts
1 site in 1 country.
About this study
Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. The level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. The purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the Epworth Sleepiness Scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.
- Conditions
- Burning Mouth Syndrome, Melatonin
- Being tested
- Epworth's sleepiness scale; unstimulated saliva sample
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epworth's sleepiness scale; unstimulated saliva sampleOther
Unstimulated saliva sample; Epworth's sleepiness scale
| Study group | Role | What they receive |
|---|---|---|
| Study group | Female patients of the Department of Oral medicine diagnosed with burning mouth syndrome Receives: Other: Epworth's sleepiness scale; unstimulated saliva sample | |
| Control group | Age-matched female patients without oral lesions and without burning mouth syndrome Receives: Other: Epworth's sleepiness scale; unstimulated saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
determining the level of salivary melatonin
The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples
Measured: January 2021-July 2021
Secondary outcomes (1)
determining the difference in Epworth's sleepiness scale
The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is graded from 0-24. 0-7:It is unlikely that you are abnormally sleepy.
8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention.
Measured: January 2021-July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start7 Jan 2021
- Primary completion18 Jul 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Božana Lončar Brzak, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309681
- Sponsor's protocol ID
- 09/2020
- Status last verified
- May 2022
- First submitted
- 24 Mar 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT05309681
- Acronym / sponsor ID
- 09/2020
- Conditions
- Burning Mouth Syndrome, Melatonin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. The level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. The purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the Epworth Sleepiness Scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Epworth's sleepiness scale; unstimulated saliva sampleFemale patients of the Department of Oral medicine diagnosed with burning mouth syndrome |
| Control group | – | Other: Epworth's sleepiness scale; unstimulated saliva sampleAge-matched female patients without oral lesions and without burning mouth syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients with burning mouth syndrome and age-matched female controls without burning mouth syndrome or oral lesions will be included in the study. A sample of unstimulated saliva will be taken from all patients and frozen. All patients will also fill in Epworth's sleepiness scale.
Key inclusion criteria (3 listed)
- female patients
- primary burning mouth syndrome
- without oral lesions
Key exclusion criteria (3 listed)
- secondary burning mouth syndrome
- male gender
- patients with oral lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epworth's sleepiness scale; unstimulated saliva sampleUnstimulated saliva sample; Epworth's sleepiness scale | Other | Control group, Study group |
Primary outcome
determining the level of salivary melatonin
Time frame: January 2021-July 2021
The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples
1 secondary outcome
determining the difference in Epworth's sleepiness scale
Time frame: January 2021-July 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
Related trials for Burning Mouth Syndrome
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
RecruitingObservational study
Reducing Patient Memory Recall in the Burning Mouth Patient Population
Burning Mouth Syndrome
Active, not recruiting
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
Burning Mouth Syndrome, Low Level Laser Therapy
Not yet recruiting
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Burning Mouth Syndrome, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burning Mouth Syndrome and Melatonin, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determining the level of salivary melatonin (time frame: January 2021-July 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.