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
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response (Others) -  Will be sent by email on request


6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2027?
   Response - Beginning 9 months and ending 36 months following article publication.
   


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

INTRODUCTION:
Molar Incisor hypomineralisation (MIH) is a prevalent dental condition that affects up to 25% of children worldwide. In general, enamel hypomineralization is caused by  disturbances in the function of ameloblast cells during any of the amelogenesis stages. MIH is believed to be due to multifactorial systemic factors that contribute to enamel hypomineralization. Its exact etiology remains uncertain. 
Clinical management of young patients with MIH affected teeth becomes more challenging due to difficulty in achieving local anesthesia as there is  chronic sub clinical inflammation caused by ingress of bacteria in the exposed dentin, this causes an altered nerve potential. Inadequate anaesthsia leads to  limited cooperation for treatment  by the young children, thus affecting the quality of the restorations

RATIONALE OF THE STUDY:
Studies have shown that cryotherapy application boosts the efficacy of pulpal anesthesia of the mandibular first permanent molars with Symptomatic Irreversible pulpitis . Therefore the efficacy of cryotherapy after Local administration is tested for pain control in patients with MIH

PROCEDURE 
Group 1 (control): A standard IANB will be administered using 2.5 mL of 2% lidocaine with 1:200000 adrenaline . The block will be
administered with a 24-Gauge, 25-mm needle (Dispovan) inserted and IANB will be given.
Group 2 (IANB+ Endo frost spray cryotherapy): A standard IANB will be administered in the same way as in the control group, then endo-frost will be applied on the buccal, lingual (3 seconds/surface), and occlusal surfaces (4 seconds) for a total of 10seconds.

The restorative procedure in both the groups will begin 10minutes after the IANB when the patient has lip numbness. Standardization of the protocol will be done by choosing the same operator, material, technique, and clinical settings. The tooth will be isolated using a rubber dam

EVALUATION
During the restorative procedure, a subjective and an observational scale is used to record the pain .
Wong-Baker FPR scale  : the patients will be instructed to report their pain again on a scale. A set of six cartoon faces were shown to the child with varying facial expressions ranging from a very smiling face to a very sad face.  

FLACC scale (Face, Legs, Activity, Cry, Consolability)  is recorded by an blinded observer.. The scale has five criteria, which are each assigned a score of 0, 1 or 2 Total scores are added from each criterion
 
EXPECTED OUTCOME:
Null hypothesis: There will be no difference in pain between local anesthesia (traditional inferior alveolar nerve block) with cryotherapy and local anesthesia (traditional inferior alveolar nerve block) during restoration of MIH affected first Permanent mandibular Molar in children.