| CTRI Number |
CTRI/2025/06/089026 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| 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)= "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)
|
01/07/2025 |
| 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="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Molar Incisor Hypomineralization (MIH) is a developmental condition affecting the enamel of first permanent molars and incisors. Its impact on Oral Health-Related Quality of Life (OHRQoL) in children can be significant, especially in terms of pain, discomfort, and social confidence. The aim of this study is to evaluate the Oral Health-Related Quality of Life (OHRQoL) and tooth sensitivity in children with and without molar incisor hypomineralization (MIH) using the child perceptions questionnaire (CPQ 8-12) and to explore the perceptions of parents and caregivers by parents and caregiver’s questionnaire (PCPQ) regarding the effect of MIH on their children’s OHRQoL. 170 Schoolchildren aged 8 to 12 years will be recruited along with their parents, to participate in the study. Both groups will complete the CPQ-8-12 and PCPQ questionnaires to gather the comprehensive data. The data obtained will be tabulated and statistically analysed. |