MenopauseNCT05335733
Menopause and Oral Microbiome
An observational study of Menopause, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Intraoral examination, saliva, dental plaque and serum collection.
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Middle aged women.
Who may be able to join
None listed.
Who cannot join
- Antibiotic useage in last 3 months Being in menopausal transition phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dental Plaque and Saliva Microbiome and Their Association With Periodontal Parameters in Premenopausal and Postmenopausal Women
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
- Being tested
- Intraoral examination, saliva, dental plaque and serum collection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women | Not described Receives: Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection. | |
| Premenopausal women | Not described Receives: Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the relative abundances of bacteria in groups, acquired by processing of Illumina sequencing data with QIIME2 bioinformatic tool.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start15 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Forsyth Institute
- Responsible party
- Principal investigator, Gülnur Emingil, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335733
- Sponsor's protocol ID
- EGE BAP-23832
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yakar N, Yilmaz B, Emingil G, Chen T, Ozdemir G, Kantarci A. Subgingival microbial profiles in pre- and postmenopausal women: Associations with serum estradiol levels. J Periodontol. 2025 Jan;96(1):97-108. doi: 10.1002/JPER.24-0267. Epub 2024 Jul 14.
PubMed 39003582
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Plaque and Saliva Microbiome and Their Association With Periodontal Parameters in Premenopausal and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05335733
- Acronym / sponsor ID
- EGE BAP-23832
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Forsyth Institute
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women | – | Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection. |
| Premenopausal women | – | Diagnostic Test: Intraoral examination, saliva, dental plaque and serum collection. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Middle aged women.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Antibiotic useage in last 3 months Being in menopausal transition phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Postmenopausal women, Premenopausal women |
Primary outcome
Differences in the relative abundances of bacteria in groups, acquired by processing of Illumina sequencing data with QIIME2 bioinformatic tool.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 39003582Yakar N, Yilmaz B, Emingil G, Chen T, Ozdemir G, Kantarci A. Subgingival microbial profiles in pre- and postmenopausal women: Associations with serum estradiol levels. J Periodontol. 2025 Jan;96(1):97-108. doi: 10.1002/JPER.24-0267. Epub 2024 Jul 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the relative abundances of bacteria in groups, acquired by processing of Illumina sequencing data with QIIME2 bioinformatic tool. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.