| CTRI Number |
CTRI/2025/06/089026 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the Impact of Molar Incisor Hypomineralization on Oral Health-
Related Quality of Life in Indian Schoolchildren Aged 8 To 12 Years. |
|
Scientific Title of Study
|
Evaluate the Impact of Molar Incisor Hypomineralization on Oral Health-
Related Quality of Life in Indian Schoolchildren Aged 8 To 12 Years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Bhouray |
| Designation |
Junior Resident |
| Affiliation |
Guru nanak dev dental college and research institute |
| Address |
83/3-B Model town, Patiala Sunam, Bathinda Rd, Patiala, Punjab 148028
Patiala PUNJAB 147001 India |
| Phone |
6239597917 |
| Fax |
|
| Email |
vanshika.8799@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vanshika Bhouray |
| Designation |
Junior Resident |
| Affiliation |
Guru nanak dev dental college and research institute |
| Address |
83/3-B Model town, Patiala Sunam, Bathinda Rd, Patiala, Punjab 148028
Patiala PUNJAB 147001 India |
| Phone |
6239597917 |
| Fax |
|
| Email |
vanshika.8799@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vanshika Bhouray |
| Designation |
Junior Resident |
| Affiliation |
Guru nanak dev dental college and research institute |
| Address |
83/3-B Model town, Patiala Sunam, Bathinda Rd, Patiala, Punjab 148028
Patiala PUNJAB 147001 India |
| Phone |
6239597917 |
| Fax |
|
| Email |
vanshika.8799@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self |
| Address |
83/3-B Model Town, Patiala |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Vanshika Bhouray |
Guru nanak dev dental college and research institute |
Sunam, patiala-bathinda road Sangrur PUNJAB |
06239597917
vanshika.8799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethical committee |
Approved |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q188||Other specified congenital malformations of face and neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
• Healthy school children aged between 8 to 12.
• At least one permanent first molar shall be present ± other teeth.
• Any presence of demarcated opacities, post-eruptive enamel breakdown, atypical restorations and extraction due to MIH in at least one permanent first permanent molar.
|
|
| ExclusionCriteria |
| Details |
• Children with systemic comorbidities, physical or mental disability and requiring special health care needs.
• Presence of orthodontic attachments that prevented the examination of the tooth surface.
• Incompletely erupted tooth.
• Tooth with recently topical fluoride application (including SDF procedure).
• Developmental anomalies related to dental hard tissue (fluorosis, amelogenesis imperfecta, enamel hypoplasia, enamel malformations due to any syndrome, etc.)
• The existence of severe malocclusion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
. To evaluate the Oral-Health Related Quality of Life (OHRQoL) in children with and without molar incisor hypomineralization (MIH) and to assess the impact of severity of MIH on OHRQoL in children using the Child Perceptions Questionnaire (CPQ 8-12)
2. To evaluate the impact of MIH on OHRQoL according to their parents /care-givers perceptions using Parental – Caregiver Perceptions Questionnaire (PCPQ).
3. To evaluate the impact of tooth sensitivity in MIH affected teeth.
|
. To evaluate the Oral-Health Related Quality of Life (OHRQoL) in children with and without molar incisor hypomineralization (MIH) and to assess the impact of severity of MIH on OHRQoL in children using the Child Perceptions Questionnaire (CPQ 8-12)
2. To evaluate the impact of MIH on OHRQoL according to their parents /care-givers perceptions using Parental – Caregiver Perceptions Questionnaire (PCPQ).
3. To evaluate the impact of tooth sensitivity in MIH affected teeth.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the impact of tooth sensitivity in MIH affected teeth.
|
|
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
10/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="30" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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)
|
This analytical cross-sectional study assessed the impact of
molar incisor hypomineralization (MIH) on oral health-related quality of life
(OHRQoL), caregiver perceptions, and dentine hypersensitivity in children aged
8–12 years (n = 170).
Primary outcomes included the Child Perceptions
Questionnaire (CPQ), Parental-Caregiver Perceptions Questionnaire (PCPQ), and
Schiff cold sensitivity scale. Children with MIH demonstrated significantly
higher CPQ scores across all domains- oral symptoms, functional limitation,
emotional, and social well-being, indicating markedly poorer OHRQoL (p <
0.001). Similarly, PCPQ findings revealed a significantly greater negative
impact on both family functioning and caregiver perception in the MIH group (p
< 0.001). Dentine hypersensitivity scores were also significantly higher in
children with MIH and showed a strong positive association with increasing
disease severity and symptom burden.
Secondary outcomes included dental fear and anxiety
(CFSS-DS) and global self-assessment of oral health and well-being. Children
with MIH exhibited significantly higher dental fear and anxiety levels (p <
0.001) and reported poorer global ratings, with the majority perceiving their
oral health and well-being as “moderate” or “poor.”
Overall, MIH was found to significantly impair quality of
life, increase hypersensitivity, and adversely affect both children and their
caregivers, highlighting the need for early diagnosis and targeted management
strategies.
|