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Completed

NCT Number: NCT04535973

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

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.

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Key information

Conditions

Burning Mouth Syndrome 17β-Estradiol Dehydroepiandrosterone Endocrine System Diseases Hormone Disturbance Mouth Diseases Progesterone Quality of Life Stomatognathic Diseases

Age range

51 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • postmenopausal women with burning mouth syndrome

Exclusion criteria

  • women with burning mouth syndrome who are not in menopause

Treatment and study plan

unstimulated saliva sample for hormone analysis

Diagnostic Test

hormone levels will be determined in frozen samples of unstimulated saliva

Quality of Life Questionnaire

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. to evaluate quality of life and correlate it with levels of salivary hormones and intensity of symptoms

    Time frame: November 2019-June 2020

    quality of life was evaluated with self-perceived questionnaire OHIP-14

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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