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Menopause and Oral Microbiome

E

Ege University

Status

Completed

Conditions

Menopause

Treatments

Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection.

Study type

Observational

Funder types

Other

Identifiers

NCT05335733
EGE BAP-23832

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

Female

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Regularly mensturating women over 35 years of age Postmenopausal women under 65 years of age

Exclusion Criteria:

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

Trial design

220 participants in 2 patient groups

Postmenopausal women
Treatment:
Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection.
Premenopausal women
Treatment:
Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection.

Trial contacts and locations

1

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Central trial contact

Nil Yakar

Data sourced from clinicaltrials.gov

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