Burning Mouth SyndromeNCT04535973
Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
An observational study of Burning Mouth Syndrome and Progesterone, run by University of Zagreb at 1 site in Croatia.
Trial summary
The aim of this study was to determine the level of salivary estradiol, progesterone and dehydroepiandrosterone in female postmenopausal women with and without burning mouth syndrome. Read more about this study
- Who is it for?
- Ages 51 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome, Progesterone, Dehydroepiandrosterone
- What is being tested?
- unstimulated saliva sample for hormone analysis and quality of life questionnaire
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Nov 2019to 15 Jun 2020
- 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 51 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: postmenopausal women are most frequently affected with burning mouth syndrome, and we wanted the groups to be as similar as possible so we included only postmenopausal women, with and without burning mouth syndrome
Who may be able to join
- postmenopausal women with burning mouth syndrome
Who cannot join
- women with burning mouth syndrome who are not in menopause
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the level of salivary estradiol, progesterone and dehydroepiandrosterone in female postmenopausal women with and without burning mouth syndrome. In all participants the quantity of unstimulated and stimulated saliva would be determined and they would fulfill self-perceived quality of life questionnaire Oral Health Impact Profile-14 (OHIP-14). Intensity of burning symptoms would be determined on visual-analogue scale grading 0-10. All data would be compared between study and control group.
- Conditions
- Burning Mouth Syndrome, Progesterone, Dehydroepiandrosterone, Quality of Life, Hormone Disturbance, 17β-Estradiol
- Being tested
- unstimulated saliva sample for hormone analysis, quality of life questionnaire
- Keywords
- burning mouth syndrome, hormonal status, quality of life
- Medical subject headings
- Burning Mouth Syndrome, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unstimulated saliva sample for hormone analysisDiagnostic test
hormone levels will be determined in frozen samples of unstimulated saliva
quality of life questionnaireOther
all participants will fill out self-perceived quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| study group | female postmenopausal women with burning mouth syndrome Receives: Diagnostic Test: unstimulated saliva sample for hormone analysis; Other: quality of life questionnaire | |
| control group | female postmenopausal women without burning mouth syndrome Receives: Diagnostic Test: unstimulated saliva sample for hormone analysis; Other: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the levels of salivary hormone
levels of salivary 17β-Estradiol, progesterone and DHEA were determined in study and control group
Measured: November 2019-June 2020
Secondary outcomes (1)
to evaluate quality of life and correlate it with levels of salivary hormones and intensity of symptoms
quality of life was evaluated with self-perceived questionnaire OHIP-14
Measured: November 2019-June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start15 Nov 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
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
- Prospective
- Enrolment
- 40 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
- NCT04535973
- Sponsor's protocol ID
- Univ Zg
- Status last verified
- Sep 2020
- First submitted
- 22 Aug 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT04535973
- Acronym / sponsor ID
- Univ Zg
- Conditions
- Burning Mouth Syndrome, Progesterone, Dehydroepiandrosterone, Quality of Life, Hormone Disturbance, 17β-Estradiol
- Keywords
- burning mouth syndrome, hormonal status, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 2 Sep 2020 (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.
The aim of this study was to determine the level of salivary estradiol, progesterone and dehydroepiandrosterone in female postmenopausal women with and without burning mouth syndrome. In all participants the quantity of unstimulated and stimulated saliva would be determined and they would fulfill self-perceived quality of life questionnaire Oral Health Impact Profile-14 (OHIP-14). Intensity of burning symptoms would be determined on visual-analogue scale grading 0-10. All data would be compared between study and control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: unstimulated saliva sample for hormone analysis, Other: quality of life questionnairefemale postmenopausal women with burning mouth syndrome |
| control group | – | Diagnostic Test: unstimulated saliva sample for hormone analysis, Other: quality of life questionnairefemale postmenopausal women without burning mouth syndrome |
Who may qualify
- Ages
- 51 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopausal women are most frequently affected with burning mouth syndrome, and we wanted the groups to be as similar as possible so we included only postmenopausal women, with and without burning mouth syndrome
Key inclusion criteria (1 listed)
- postmenopausal women with burning mouth syndrome
Key exclusion criteria (1 listed)
- women with burning mouth syndrome who are not in menopause
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 |
|---|---|---|
| unstimulated saliva sample for hormone analysishormone levels will be determined in frozen samples of unstimulated saliva | Diagnostic test | control group, study group |
| quality of life questionnaireall participants will fill out self-perceived quality of life questionnaire | Other | control group, study group |
Primary outcome
to evaluate the levels of salivary hormone
Time frame: November 2019-June 2020
levels of salivary 17β-Estradiol, progesterone and DHEA were determined in study and control group
1 secondary outcome
to evaluate quality of life and correlate it with levels of salivary hormones and intensity of symptoms
Time frame: November 2019-June 2020
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 2 Sep 2020.
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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 Progesterone, 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 1 inclusion and 1 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 2 Sep 2020. 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?
to evaluate the levels of salivary hormone (time frame: November 2019-June 2020). 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 2 Sep 2020.