Menopause and Oral Microbiome

Completed

• Conditions: Menopause
• Interventions: Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection.

• Registration Number: NCT05335733
• Lead Sponsor: Ege University

Brief Summary

The study examines the saliva and dental plaque microbiome of women aged 35-65 in two groups: postmenopausal (case) and premenopausal (control). For this purpose, Illumina Platform to sequence 16S rRNA gene regions will be used. The data will be analyzed using the QIIME2 bioinformatics tool. Serum estradiol levels will be determined by the ELISA method. The investigators will examine the relationship between microbiome data (alpha diversity, beta diversity, and relative abundance) and menopausal status, estradiol levels, and periodontal health status using linear statistical models. Clinical samples of the study will be collected at Ege University, and the laboratory studies and sequence analysis will be conducted at the Forsyth Institute in Boston.

To obtain longitudinal data besides the cross-sectional data, the investigators will contact the participants of a previous study from 2019, whose saliva, dental plaque, and serum samples are currently being stored at -80 °C, and ask them to participate for a second sampling.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-19
• Primary Completion: 2022-12-30
• Study Completion: 2023-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

• Antibiotic useage in last 3 months Being in menopausal transition phase

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postmenopausal women	Intraoral examination, saliva, dental plaque and serum collection.	-
Premenopausal women	Intraoral examination, saliva, dental plaque and serum collection.	-

Primary Outcome Measures

Name	Time	Method
Differences in the relative abundances of bacteria in groups, acquired by processing of Illumina sequencing data with QIIME2 bioinformatic tool.	1 year

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey