Menopause and Oral Microbiome

NCT05335733 | Completed

• 1 other identifier: EGE BAP-23832
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

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

  1 year

Study Arms (2)

Postmenopausal women

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

Premenopausal women

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

Interventions

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.

Postmenopausal women; Premenopausal women

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Middle aged women.

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead
• The Forsyth Institute: collaborator

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 19, 2022
• Study Start: February 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: October 30, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

TU (1)