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NCT04535973 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04535973
Other study ID # Univ Zg
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2019
Est. completion date June 15, 2020

Study information
Verified date September 2020
Source University of Zagreb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 51 Years to 75 Years
Eligibility Inclusion Criteria:

- postmenopausal women with burning mouth syndrome

Exclusion Criteria:

- women with burning mouth syndrome who are not in menopause

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• unstimulated saliva sample for hormone analysis
hormone levels will be determined in frozen samples of unstimulated saliva
Other:
• quality of life questionnaire
all participants will fill out self-perceived quality of life questionnaire

Locations
Country Name City State
Croatia School of Dental Medicine, University of Zagreb Zagreb

Sponsors (1)
Lead Sponsor Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary to evaluate the levels of salivary hormone levels of salivary 17ß-Estradiol, progesterone and DHEA were determined in study and control group November 2019-June 2020
Secondary 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
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