| CTRI Number |
CTRI/2025/07/090773 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding hormonal changes and dental caries in pre-menopausal and post-Menopause |
|
Scientific Title of Study
|
A cross sectional study to investigate the relationship between hormonal changes occurring post menopause and dental caries: a biomarker perspective |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhipsha Lahiri |
| Designation |
Assistant Professor |
| Affiliation |
Siddhpur Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
Siddhpur Dental College and Hospital, Dethali, Siddhpur
Patan
GUJARAT
384151
India |
| Phone |
9664524347 |
| Fax |
|
| Email |
abhipshalahiri90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
government dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
government dental college and hospital, civil campus, asarwa, ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
shikhakk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhipsha Lahiri |
| Designation |
Assistant Professor |
| Affiliation |
Siddhpur Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
Siddhpur Dental College and Hospital, Dethali, Siddhpur
Patan
GUJARAT
384151
India |
| Phone |
9664524347 |
| Fax |
|
| Email |
abhipshalahiri90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontic, Siddhpur Dental College and Hopital, Patan, Gujarat 384151 |
|
|
Primary Sponsor
|
| Name |
Siddhpur Dental College and Hopital |
| Address |
Siddhpur Dental College and Hopital, Patan, Gujarat 384151 |
| Type of Sponsor |
Other [Government Dental College] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhipsha Lahiri |
Siddhpur Dental College and Hospital |
Department of Conservative dentistry and Endodontics, Siddhpur Dental College and Hospital, Dethali, Patan- 384151
Patan
GUJARAT |
9664524347
abhipshalahiri90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Dental College and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Premenopausal healthy women in the age group of 35-50years with no caries and having regular menstrual cycles.
Post menopausal (51-65years old) women with and without caries with history of menopause for more than one year.
|
|
| ExclusionCriteria |
| Details |
Women with any chronic diseases such as diabetes, chronic liver/renal diseases.
Women with any habits such as cigarette smoking, drinking alcohol
Individuals on hormone replacement therapy
Individual using any medicine on a regular basis that affects the salivary flow.
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A positive correlation between dental caries and pH level, salivary flow, salivary calcium, estradiol level and Vitamin D level in serum |
checked within a day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine if there is any correlation between salivary flow, salivary pH, hormonal fluctuations & micronutrient level to Dental Caries.
To evaluate & compare the flow & pH of saliva in Premenopausal & Post menopausal women.
To evaluate & compare the salivary Calcium of Premenopausal & post menopausal women.
To evaluate & compare the Estrogen (Estradiol) & Vitamin D level in serum of Premenopausal & post menopausal women.
|
to be evaluated within a day |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cross sectional study to investigate the relationship between hormonal changes occurring post menopause and dental caries: A biomarker perspective. The aim is to evaluate the relationship between hormonal changes occurring post menopause and dental caries using biomarkers. To determine if there is any correlation between salivary flow, salivary pH, hormonal fluctuations and micronutrient level to Dental Caries. To evaluate and compare the flow and pH of saliva in Premenopausal and Post menopausal women. To evaluate and compare the salivary Calcium of Premenopausal and post menopausal women. To evaluate and compare the Estrogen (Estradiol) and Vitamin D level in serum of Premenopausal and post menopausal women.
|