NCT04535973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

August 22, 2020

Last Update Submit

September 1, 2020

Conditions

Burning Mouth SyndromeProgesteroneDehydroepiandrosteroneQuality of LifeHormone Disturbance17β-Estradiol

Keywords

burning mouth syndromehormonal statusquality of life

Outcome Measures

Primary Outcomes (1)

  • to evaluate the levels of salivary hormone

    levels of salivary 17β-Estradiol, progesterone and DHEA were determined in study and control group

    November 2019-June 2020

Secondary Outcomes (1)

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

    November 2019-June 2020

Study Arms (2)

study group

female postmenopausal women with burning mouth syndrome

Diagnostic Test: unstimulated saliva sample for hormone analysisOther: quality of life questionnaire

control group

female postmenopausal women without burning mouth syndrome

Diagnostic Test: unstimulated saliva sample for hormone analysisOther: quality of life questionnaire

Interventions

unstimulated saliva sample for hormone analysisDIAGNOSTIC_TEST

hormone levels will be determined in frozen samples of unstimulated saliva

control groupstudy group
quality of life questionnaireOTHER

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

control groupstudy group

Eligibility Criteria

Age51 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • postmenopausal women with burning mouth syndrome

You may not qualify if:

  • women with burning mouth syndrome who are not in menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Burning Mouth SyndromeEndocrine System Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2020

First Posted

September 2, 2020

Study Start

November 15, 2019

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

CR(1)