Menopause and Oral Health

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05513118
• Other study ID #: TOA-2020-21085
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: September 2022
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause
• Periodontal Diseases

Intervention

Diagnostic Test:
• Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling
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.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Dentistry	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Karolinska Institutet

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month