Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 12:10 AM
Study NCT ID:
NCT05205057
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salivary Calcium in Post-menopausal Women and Prevalence of Dental Caries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-23', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary calcium', 'timeFrame': '2 months', 'description': 'Salivary calcium change'}], 'secondaryOutcomes': [{'measure': 'Dental caries', 'timeFrame': '2 months', 'description': 'Dental caries change'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-menopausal', 'Post-menopausal', 'salivary calcium', 'dental caries'], 'conditions': ['Salivary Calcium']}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No metabolic disorders\n* No medications taken in the past 3 months\n* No periodontal disease\n\nExclusion Criteria:\n\n* Periodontal disease present\n* Metabolic disease present\n* Medications taken in the past 3 months'}, 'identificationModule': {'nctId': 'NCT05205057', 'briefTitle': 'Salivary Calcium in Post-menopausal Women and Prevalence of Dental Caries', 'organization': {'class': 'OTHER', 'fullName': 'Ajman University'}, 'officialTitle': 'Salivary Calcium in Post-menopausal Women and Prevalence of Dental Caries', 'orgStudyIdInfo': {'id': 'ABSM/EC22/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-menopausal', 'description': 'Pre-menopausal women', 'interventionNames': ['Other: Saliva']}, {'label': 'Post-menopausal women', 'description': 'post-menopausal women', 'interventionNames': ['Other: Saliva']}], 'interventions': [{'name': 'Saliva', 'type': 'OTHER', 'description': 'Unstimulated whole saliva is collected', 'armGroupLabels': ['Post-menopausal women', 'Pre-menopausal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '009716', 'city': 'Mangaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'AB shetty Institute of dental sciences', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'All the results will be shared and attached in the repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'sudhir rama varma', 'investigatorAffiliation': 'Ajman University'}}}}