Salivary CalciumNCT05205057
Salivary Calcium in Post-menopausal Women and Prevalence of Dental Caries
An observational study of Salivary Calcium, run by Ajman University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Salivary Calcium
- What is being tested?
- Saliva
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to 20 Oct 2021
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- No metabolic disorders
- No medications taken in the past 3 months
- No periodontal disease
Who cannot join
- Periodontal disease present
- Metabolic disease present
- Medications taken in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Salivary Calcium
- Being tested
- Saliva
- Keywords
- pre-menopausal, Post-menopausal, salivary calcium, dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalivaOther
Unstimulated whole saliva is collected
| Study group | Role | What they receive |
|---|---|---|
| Pre-menopausal | Pre-menopausal women Receives: Other: Saliva | |
| Post-menopausal women | post-menopausal women Receives: Other: Saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary calcium
Salivary calcium change
Measured: 2 months
Secondary outcomes (1)
Dental caries
Dental caries change
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Aug 2021
- Primary completion15 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary CalciumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205057
- Sponsor's protocol ID
- ABSM/EC22/2018
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the results will be shared and attached in the repository
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Calcium in Post-menopausal Women and Prevalence of Dental Caries
- ClinicalTrials.gov ID
- NCT05205057
- Acronym / sponsor ID
- ABSM/EC22/2018
- Conditions
- Salivary Calcium
- Keywords
- pre-menopausal, Post-menopausal, salivary calcium, dental caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-menopausal | – | Other: SalivaPre-menopausal women |
| Post-menopausal women | – | Other: Salivapost-menopausal women |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- No metabolic disorders
- No medications taken in the past 3 months
- No periodontal disease
Key exclusion criteria (3 listed)
- Periodontal disease present
- Metabolic disease present
- Medications taken in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalivaUnstimulated whole saliva is collected | Other | Post-menopausal women, Pre-menopausal |
Primary outcome
Salivary calcium
Time frame: 2 months
Salivary calcium change
1 secondary outcome
Dental caries
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: Yes. All the results will be shared and attached in the repository
Related trials for Salivary Calcium
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Calcium, run by Ajman University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary calcium (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.