Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome

Conditions
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Burning Mouth Syndrome, Progesterone, Dehydroepiandrosterone, Quality of Life, Hormone Disturbance, 17β-Estradiol

Intervention / Treatment
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* Diagnostic Test: unstimulated saliva sample for hormone analysis
* Other: quality of life questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postmenopausal women with burning mouth syndrome Exclusion Criteria: women with burning mouth syndrome who are not in menopause

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>female postmenopausal women with burning mouth syndrome | Diagnostic Test: unstimulated saliva sample for hormone analysis<br>* hormone levels will be determined in frozen samples of unstimulated saliva<br>Other: quality of life questionnaire<br>* all participants will fill out self-perceived quality of life questionnaire<br>|
| control group<br>female postmenopausal women without burning mouth syndrome | Diagnostic Test: unstimulated saliva sample for hormone analysis<br>* hormone levels will be determined in frozen samples of unstimulated saliva<br>Other: quality of life questionnaire<br>* all participants will fill out self-perceived quality of life questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the levels of salivary hormone | levels of salivary 17β-Estradiol, progesterone and DHEA were determined in study and control group | November 2019-June 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | November 2019-June 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burning mouth syndrome, hormonal status, quality of life