MenopauseNCT05513118
Menopause and Oral Health
An observational study of Menopause and Periodontal Diseases, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). 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, Periodontal Diseases
- What is being tested?
- Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 31 Oct 2019
- How long will I take part?
- 1 Year
- 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: Study population comprised of two main groups as postmenopausal women (PMW) and regularly menstruating women (RMW). The women in the PMW group were included if they were under 65 years of age and had a history of spontaneous amenorrhea for the last 12 months.
Who may be able to join
- Being 35-65 years of age
- Having history of spontaneous amenorrhea for the last 12 months for PMW.
- Lack of irregularity in menstrual cycles during the past 12 months for RMPW.
- Possessing at least 10 natural teeth without any prosthetic restoration
Who cannot join
- History of antibiotics use in last 3 months
- Ongoing cancer therapy
- Presence of oral ulcers or acute infectious disease
- Presence of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Menopause and Periodontal Health With Biochemical and Microbiological Parameters
Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. The participants were asked to complete the Women's Health Questionnaire to measure emotional and physical well-being.
A total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass indices (BMI) were obtained from their medical records.
- Conditions
- Menopause, Periodontal Diseases
- Being tested
- Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum samplingDiagnostic test
Probing pocket depth was 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) was measured as distance from cementoenamel junction to the base of pocket and recorded manually to the nearest millimeter marking on probe.
1 mililiter of saliva was obtained by each participant. Subgingival dental plaque was collected with sterile endodontic paperpoints from mesial sides of each natural teeth without a prostethic restoration. Gingival crevicular fluid samples were collected with absorbent paper strips. Serum samples were also collected at the time of visit.
| Study group | Role | What they receive |
|---|---|---|
| Post-menopausal women | Not described Receives: Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling | |
| Regularly mensturating women | Not described Receives: Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontitis
Interdental attachment loss is detectable at ≥2 non-adjacent teeth, or buccal/oral attachment loss ≥3 mm with pocketing >3 mm at ≥2 adjacent teeth were present.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Mar 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
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.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 148 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Gülnur Emingil, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513118
- Sponsor's protocol ID
- TOA-2020-21085
- Status last verified
- Sep 2022
- First submitted
- 21 Aug 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yakar N, Bostanci N, Ozdemir G, Atmaca H, Turedi A, Sahin C, Kose T, Emingil G. Salivary inflammatory burden in pre- and postmenopausal women: Associations with body mass index, patient-reported health, serum cytokines, and periodontal parameters. J Periodontol. 2024 Mar;95(3):209-218. doi: 10.1002/JPER.23-0124. Epub 2023 Oct 18.
PubMed 37851637
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Menopause and Periodontal Health With Biochemical and Microbiological Parameters
- ClinicalTrials.gov ID
- NCT05513118
- Acronym / sponsor ID
- TOA-2020-21085
- Conditions
- Menopause, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 24 Aug 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.
Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. The participants were asked to complete the Women's Health Questionnaire to measure emotional and physical well-being.
A total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass indices (BMI) were obtained from their medical records.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-menopausal women | – | Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling |
| Regularly mensturating women | – | Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population comprised of two main groups as postmenopausal women (PMW) and regularly menstruating women (RMW). The women in the PMW group were included if they were under 65 years of age and had a history of spontaneous amenorrhea for the last 12 months.
Key inclusion criteria (4 listed)
- Being 35-65 years of age
- Having history of spontaneous amenorrhea for the last 12 months for PMW.
- Lack of irregularity in menstrual cycles during the past 12 months for RMPW.
- Possessing at least 10 natural teeth without any prosthetic restoration
Key exclusion criteria (4 listed)
- History of antibiotics use in last 3 months
- Ongoing cancer therapy
- Presence of oral ulcers or acute infectious disease
- Presence of diabetes mellitus
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 |
|---|---|---|
| Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum samplingProbing pocket depth was 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) was measured as distance from cementoenamel junction to the base of pocket and recorded manually to the nearest millimeter marking on probe. 1 mililiter of saliva was obtained by each participant. Subgingival dental plaque was collected with sterile endodontic paperpoints from mesial sides of each natural teeth without a prostethic restoration. Gingival crevicular fluid samples were collected with absorbent paper strips. Serum samples were also collected at the time of visit. | Diagnostic test | Post-menopausal women, Regularly mensturating women |
Primary outcome
Periodontitis
Time frame: 1 month
Interdental attachment loss is detectable at ≥2 non-adjacent teeth, or buccal/oral attachment loss ≥3 mm with pocketing >3 mm at ≥2 adjacent teeth were present.
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 30 Sep 2022.
- Derived from this study: PubMed 37851637Yakar N, Bostanci N, Ozdemir G, Atmaca H, Turedi A, Sahin C, Kose T, Emingil G. Salivary inflammatory burden in pre- and postmenopausal women: Associations with body mass index, patient-reported health, serum cytokines, and periodontal parameters. J Periodontol. 2024 Mar;95(3):209-218. doi: 10.1002/JPER.23-0124. Epub 2023 Oct 18.
- 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 and Periodontal Diseases, 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 4 inclusion and 4 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 30 Sep 2022. 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?
Periodontitis (time frame: 1 month). 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 NCT05513118, 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 30 Sep 2022.