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

September 1, 2020 updated by: Božana Lončar Brzak, University of Zagreb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • School of Dental Medicine, University of Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

postmenopausal women are most frequently affected with burning mouth syndrome, and we wanted the groups to be as similar as possible so we included only postmenopausal women, with and without burning mouth syndrome

Description

Inclusion Criteria:

  • postmenopausal women with burning mouth syndrome

Exclusion Criteria:

  • women with burning mouth syndrome who are not in menopause

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
female postmenopausal women with burning mouth syndrome
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
control group
female postmenopausal women without burning mouth syndrome
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: November 2019-June 2020
quality of life was evaluated with self-perceived questionnaire OHIP-14
November 2019-June 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

August 22, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Univ Zg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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