Zirconia Reinforced Glass Ionomer in MIH

Hams Hamed Abdelrahman88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Molar Incisor Hypomineralization

Interventions

zirconomerOTHER

teeth meeting the inclusion criteria are assigned to receive Zirconomer® restorations

HVGI-Equia ForteOTHER

teeth meeting the inclusion criteria are assigned to receive HVGI-Equia Forte® restorations.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Outcomes

Primary Outcomes

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.

Time frame: at 3 months, 6 months, 9 months, 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

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