Zirconia Reinforced Glass Ionomer in MIH

Study Overview
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Brief Summary
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Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. It can be very beneficial in managing MIH-affected molars in communities with limited access to dental care. Zirconia-reinforced GI was recently introduced. It is claimed to serve as a long-term temporary restoration until a more permanent restoration is placed

Official Title
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Effectiveness Of Zirconia Reinforced Glass Ionomer Used In Alternative Restorative Treatment In Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial And Finite Element Analysis)

Conditions
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Molar Incisor Hypomineralization

Intervention / Treatment
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* Other: zirconomer
* Other: HVGI-Equia Forte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children free from any systemic disease (ASA I). Cooperative children showing positive or definitely positive behavior according to Frankl rating scale Hypomineralized first permanent molars that are restorable according to MIH Treatment Need Index (MIH-TNI): Index (2a), (2b), (4a), (4b) Teeth with dentinal lesions corresponding to ICDAS II score 5 or 6 No clinical or radiographic evidence of pulpal involvement. Exclusion Criteria: Index (0), (1), (2c), (3), (4c) on the MIH Treatment Need Index. Patients whose parents will not give their consent to participate in the study Non-restorable first permanent molars indicated for extraction

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Other: zirconomer<br>* teeth meeting the inclusion criteria are assigned to receive Zirconomer® restorations<br>|
| Active Comparator: Control<br> | Other: HVGI-Equia Forte<br>* teeth meeting the inclusion criteria are assigned to receive HVGI-Equia Forte® restorations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical success rate | It will be assessed using Modified ART criteria, restorations receiving a score of: (0) Restoration is present and satisfactory OR (1) Restoration is present, slight defect at the cavity margin of less than 0.5 mm; no repair is needed. will be considered successful, and any other score will be considered a failure. | at 3 months, 6 months, 9 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Pain will be recorded using VAS Using a visual analog scale (VAS), the subjects were instructed how to point to the position of the line between faces to indicate how much painthey might feel. In this system, the total scores range from 0 to 100 based on measuring the distance in millimeters from the left end bar to the mark made by the child on the 10 cm line anchored by happy to sad faces, with a higher score indicating more severe pain. | at 1 week, 3 months, 6 months, 9 months, 12 months | 
| Change in sensitivity | sensitivity will be recorded using VAS by performing air blast test Using a visual analog scale (VAS), the subjects were instructed how to point to the position of the line between faces to indicate how much pain they might feel. In this system, the total scores range from 0 to 100 based on measuring the distance in millimeters from the left end bar to the mark made by the child on the 10 cm line anchored by happy to sad faces, with a higher score indicating more severe pain. | at 1 week, 3 months, 6 months, 9 months, 12 months | 
| Finite element analysis | Performance of both Zirconomer and HVGI-Equia Forte under dynamic occlusal loads will be assessed using Finite Element Analysis using ANSYS software. | 12 months |