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

Completed

• Conditions: Burning Mouth Syndrome; Dehydroepiandrosterone; Progesterone; 17β-Estradiol; Quality of Life; Hormone Disturbance
• Interventions: Diagnostic Test: unstimulated saliva sample for hormone analysis; Other: quality of life questionnaire

• Registration Number: NCT04535973
• Lead Sponsor: University of Zagreb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Study First Submitted: 2020-08-22
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-02
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• postmenopausal women with burning mouth syndrome

Exclusion Criteria

• women with burning mouth syndrome who are not in menopause

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	unstimulated saliva sample for hormone analysis	female postmenopausal women with burning mouth syndrome
control group	unstimulated saliva sample for hormone analysis	female postmenopausal women without burning mouth syndrome
study group	quality of life questionnaire	female postmenopausal women with burning mouth syndrome
control group	quality of life questionnaire	female postmenopausal women without burning mouth syndrome

Primary Outcome Measures

Name	Time	Method
to evaluate the levels of salivary hormone	November 2019-June 2020	levels of salivary 17β-Estradiol, progesterone and DHEA were determined in study and control group

Secondary Outcome Measures

Name	Time	Method
to evaluate quality of life and correlate it with levels of salivary hormones and intensity of symptoms	November 2019-June 2020	quality of life was evaluated with self-perceived questionnaire OHIP-14

Trial Locations

Locations (1)

School of Dental Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia