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OpenTrials
Completed

NCT Number: NCT05513118

Menopause and Oral Health

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ege University Faculty of Dentistry

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling

Diagnostic 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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Evaluation of the Relationship Between Menopause and Periodontal Health With Biochemical and Microbiological Parameters

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2022
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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