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

NCT ID: NCT04535973

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-06-15

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

female postmenopausal women with burning mouth syndrome

unstimulated saliva sample for hormone analysis

Intervention Type DIAGNOSTIC_TEST

hormone levels will be determined in frozen samples of unstimulated saliva

quality of life questionnaire

Intervention Type OTHER

all participants will fill out self-perceived quality of life questionnaire

control group

female postmenopausal women without burning mouth syndrome

unstimulated saliva sample for hormone analysis

Intervention Type DIAGNOSTIC_TEST

hormone levels will be determined in frozen samples of unstimulated saliva

quality of life questionnaire

Intervention Type OTHER

all participants will fill out self-perceived quality of life questionnaire

Interventions

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unstimulated saliva sample for hormone analysis

hormone levels will be determined in frozen samples of unstimulated saliva

Intervention Type DIAGNOSTIC_TEST

quality of life questionnaire

all participants will fill out self-perceived quality of life questionnaire

Intervention Type OTHER

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
Minimum Eligible Age

51 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Božana Lončar Brzak

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dental Medicine, University of Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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Univ Zg

Identifier Type: -

Identifier Source: org_study_id

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