| CTRI Number |
CTRI/2026/04/107391 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
11/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk factor for Molar Incisor hypomineralization |
|
Scientific Title of Study
|
Prenatal, Natal and Postnatal Risk Factors for Molar Incisor Hypomineralization in Children- A Case Control Study |
| 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 Parthipann J |
| Designation |
PG - Student |
| Affiliation |
KSR Institute of dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode
KSR Institute of Dental Science and Research, KSR Kalvi Nagar Tiruchengode
Namakkal
TAMIL NADU
637215
India |
| Phone |
6381367380 |
| Fax |
|
| Email |
pedodales05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharath Asolan |
| Designation |
Principal & Professor |
| Affiliation |
KSR Institute of dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode
KSR Institute of Dental Science and Research, KSR Kalvi Nagar Tiruchengode
Namakkal
TAMIL NADU
637215
India |
| Phone |
9840168772 |
| Fax |
|
| Email |
asokansharath@ksridsr.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parthipann J |
| Designation |
PG - Student |
| Affiliation |
KSR Institute of dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode
KSR Institute of Dental Science and Research, KSR Kalvi Nagar Tiruchengode
Namakkal
TAMIL NADU
637215
India |
| Phone |
6381367380 |
| Fax |
|
| Email |
pedodales05@gmail.com |
|
|
Source of Monetary or Material Support
|
| KSR Institute of Dental Science and Research |
|
|
Primary Sponsor
|
| Name |
KSR Institute of Dental Science and Research |
| Address |
KSR Educational Institutions,
KSR Kalvi Nagar, Kuchipalayam PO, Tiruchengode – 637215
Namakkal District, Tamil Nadu, INDIA
|
| Type of Sponsor |
Other [Private 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 Parthipann J |
KSRIDSR |
Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode
KSR Institute of Dental Science and Research, KSR Kalvi Nagar Tiruchengode
Namakkal
TAMIL NADU |
06381367380
pedodales05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSR Institute of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children Well Demarcated Opacitiest on the First permanent molars and Incisors |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of Risk factors through a questionnaire |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2026 |
| Date of Study Completion (India) |
09/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a Case-Control study to determine the association of Prenatal. Natal and Postnatal Risk Factors with MIH among Children Aged 7-12 years from urban, suburban and tribal population of western Tamil Nadu. |