Menopause and Oral Microbiome

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.

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Key information

Conditions

Menopause

Age range

35 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ege University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intraoral examination, saliva, dental plaque and serum collection.

Diagnostic Test

Probing pocket depth will be defined as the distance in millimeters from the gingival margin to the base of the gingival sulcus measured using a manual probe (Michigan 0 probe with Williams Markings) in all the teeth present except for third molars. Similarly, clinical attachment level (CAL) will be measured as distance from cementoenamel junction to the base of pocket and will be recorded manually to the nearest millimeter marking on probe.

1 mililiter of saliva will be obtained by each participant. Subgingival dental plaque will be collected with sterile endodontic paperpoints from mesial sides of each natural teeth without a prostethic restoration. Serum samples will be also collected at the time of visit.

Primary outcomes

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

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

The Forsyth Institute

Registry information

Official study title

Evaluation of Dental Plaque and Saliva Microbiome and Their Association With Periodontal Parameters in Premenopausal and Postmenopausal Women

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Apr 19, 2022
Registry last updated: Jan 2, 2024

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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