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OpenTrials
Completed

NCT Number: NCT05205057

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

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

AB shetty Institute of dental sciences

Mangaluru, Karnataka, 009716, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saliva

Other

Unstimulated whole saliva is collected

Primary outcomes

  1. Salivary calcium

    Time frame: 2 months

    Salivary calcium change

Secondary outcomes

  1. Dental caries

    Time frame: 2 months

    Dental caries change

Sponsors and collaborators

Lead sponsor

Ajman University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2022
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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