1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [anjalichandran1913@gmail.com ].
   


6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

o  Introduction

MIH-affected children face a number of difficulties in their daily life.  Due to the porosity in severely affected enamel, masticatory forces break down the tooth surfaces, resulting in unprotective dentine in large atypical cavities and esthetics . These problems described above may affect oral health–related quality of life (OHRQoL) in MIH patients.

Research Question: Is there any negative impact of MIH on the quality of life in children between 8 and 10 years? 

Null Hypothesis: There is no significant association between MIH and quality of life in 8–10-year-old children.

Methods Of Data Collection

This study will be conducted among school children between 8 and 10 years old in Kannur District of Kerala State. Informed consent of each subject and his/her parent/guardian will be obtained prior to the clinical oral examination and interview.

The objective of the study and the relevant details will be explained in simple language. EAPD scoring criteria (Ghanim et al., 2011) will be used for scoring MIH. As per the sample size 100 cases affected by MIH and 100 cases without MIH will be identified. Oral examinations of the children will be performed with the child in a sitting position in broad day light.

To assess the child’s quality of life, the validated Malayalam version of the CPQ8-10 will be used. The CPQ8-10 contains a total of 25 items which can be subdivided into four domains: oral symptoms (5 items), functional limitations (5 items), emotional well-being (5 items), and social well-being (10 items).

Responses are made on an ordinal scale (0=never, 1=once/twice, 2=sometimes, 3=often, 4=every day/almost every day). Higher scores refer to a worse quality of life status. Summing the response codes for the questionnaire items generates domain scores/ sub-scales and an overall CPQ-8-10 score. The instrument’s summary score ranges from 0 to 100. A summary score of zero indicates the absence of any problems, and higher CPQ scores represent more impaired quality of life.