Menopause and Oral Health

Completed

• Conditions: Menopause; Periodontal Diseases
• Interventions: Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling

• Registration Number: NCT05513118
• Lead Sponsor: Ege University

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-21
• Study First Posted: 2022-08-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regularly mensturating women	Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling	-
Post-menopausal women	Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling	-

Primary Outcome Measures

Name	Time	Method
Periodontitis	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.

Trial Locations

Locations (1)

Ege University Faculty of Dentistry; 🇹🇷 İzmir, Turkey