Menopause and Oral Health

September 29, 2022 updated by: Gülnur Emingil, Ege University

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • İzmir, Turkey
        • Ege University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of antibiotics use in last 3 months
  • Ongoing cancer therapy
  • Presence of oral ulcers or acute infectious disease
  • Presence of diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-menopausal women

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.

Regularly mensturating women

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (ACTUAL)

August 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • TOA-2020-21085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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