Menopause and Oral Microbiome

NCT ID: NCT05335733

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-10-30

Brief Summary

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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

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Conditions

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Menopause

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Postmenopausal women

Intraoral examination, saliva, dental plaque and serum collection.

Intervention Type 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.

Premenopausal women

Intraoral examination, saliva, dental plaque and serum collection.

Intervention Type 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.

Interventions

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Intraoral examination, saliva, dental plaque and serum collection.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\- Antibiotic useage in last 3 months Being in menopausal transition phase
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Forsyth Institute

OTHER

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role lead

Responsible Party

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Gülnur Emingil

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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EGE BAP-23832

Identifier Type: -

Identifier Source: org_study_id

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