Clinical Trials Directory

Trials / Completed

CompletedNCT05513118

Menopause and Oral Health

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

Status
Completed
Phase
Study type
Observational
Enrollment
148 (actual)
Sponsor
Ege University · Academic / Other
Sex
Female
Age
35 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPeriodontal 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.

Timeline

Start date
2019-03-01
Primary completion
2019-10-31
Completion
2019-10-31
First posted
2022-08-24
Last updated
2022-09-30

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05513118. Inclusion in this directory is not an endorsement.