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

NCT05205057 | Completed

• 1 other identifier: ABSM/EC22/2018
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Salivary Calcium

Keywords

pre-menopausal; Post-menopausal; salivary calcium; dental caries

Outcome Measures

Primary Outcomes (1)

• Salivary calcium

  Salivary calcium change

  2 months

Secondary Outcomes (1)

• Dental caries

  2 months

Study Arms (2)

Pre-menopausal

Pre-menopausal women

Other: Saliva

Post-menopausal women

post-menopausal women

Other: Saliva

Interventions

Saliva OTHER

Unstimulated whole saliva is collected

Post-menopausal women; Pre-menopausal

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

AB shetty Institute of dental sciences

Mangaluru, Karnataka, 009716, India

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: August 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 20, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years

Locations

IN (1)