Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 6:47 PM
Ignite Modification Date: 2025-12-24 @ 6:47 PM
NCT ID: NCT05205057
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
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: NCT05205057
Study Brief:
Protocol Section: NCT05205057