Salivary Calcium in Post-menopausal Women and Prevalence of Dental Caries

Different phases of a woman's life are puberty, menses, pregnancy, and menopause. Menopause is one of the normal developmental stages in a woman's life, marks the permanent cessation of menstruation. It occurs due to irreversible changes in the hormones.The gradual variation and circulating sex hormones affect women's psychological balance and quality of life. The hormonal changes affect the reproductory system and affect the bone integrity and overall health of the individual. The only source of oocytes in women is an ovary. That is the primary source of oestrogens and progesterone, majorly the androgens. Therefore, various systemic health concerns like vasomotor symptoms, cardiovascular diseases, cancer, sexual problems, osteoporosis, and poor oral health

Study Overview

• Status: Completed
• Conditions: Salivary Calcium
• Intervention / Treatment: Other: Saliva

Detailed Description

The presence of estrogen receptors detected through immunohistochemistry in the oral cavity plays a significant role in associating the effect of post-menopausal conditions to variations in the oral environment like salivary hypofunction, oral discomfort, and oral mucosal disorders. The vaginal mucosa and oral mucosa are similar histologically due to stratified squamous epithelium and desquamative growth pattern. Therefore, the variation in hormonal status in post-menopausal women may lead to the proliferation and maturation of oral epithelium in response to circulating estrogens. The keratinocytes and fibroblasts in the gingival tissues are majorly targeted by estrogen leading to periodontitis, fibroblastic hyperplasia, and desquamatic lesions. Therefore, it is a proven fact that gingiva is a traditional estrogen target, leading to the destruction of supporting structures of a tooth, causing periodontitis and thereby exposing tooth structure. Another primary oral manifestation in menopausal women is xerostomia/dryness of the mouth. The salivary components provide defense by maintaining the desired pH and decreasing the prevalence of caries, but estrogen levels directly decrease the salivary flow rate. Thus, the prevalent acidic pH causes demineralization and destruction of enamel, dentin making it more susceptible to dental caries.

A correlation between bone mineral density, salivary calcium levels, and estrogen levels is already established. Hence, the salivary calcium levels can indicate increased demineralization of tooth surface and osteoporosis in menopausal. Hence, the present focuses on estimating salivary calcium levels and their association with the prevalence of dental caries in post-menopausal women.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Mangaluru, Karnataka, India, 009716
      • AB shetty Institute of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study was conducted among 40 post-menopausal women and 40 premenopausal women reporting to the OPD department of conservative dentistry and endodontics for a regular dental checkup. Individuals with metabolic disorders were and under supplementation were excluded. Women under the age group of 50 - 70 Y were included. Informed consent was obtained, DMFT index was recorded, and unstimulated salivary samples were collected with tarson's collection tubes. Individuals in the case group were further divided into three groups based on their caries experience into group 1: DMFT (D=1); group 2: DMFT(D=2-10), group 3: DMFT <10). The control group included individuals with no caries experience (D=0) and individuals who have not attained their menopause

Description

Inclusion Criteria:

• No metabolic disorders
• No medications taken in the past 3 months
• No periodontal disease

Exclusion Criteria:

• Periodontal disease present
• Metabolic disease present
• Medications taken in the past 3 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-menopausal; Pre-menopausal women	Other: Saliva; Unstimulated whole saliva is collected
Post-menopausal women; post-menopausal women	Other: Saliva; Unstimulated whole saliva is collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary calcium	Salivary calcium change	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental caries	Dental caries change	2 months

Collaborators and Investigators

• Sponsor: Ajman University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Post-menopausal; dental caries; pre-menopausal; salivary calcium
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: ABSM/EC22/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All the results will be shared and attached in the repository
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No