Zirconia Reinforced Glass Ionomer in MIH

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

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 Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Other: zirconomer; Other: HVGI-Equia Forte

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman
• Investigators: Principal Investigator: Reham A Mahfouz, MSc, Alexandria University, Faculty of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Dental Enamel Hypoplasia; Molar Hypomineralization
• Other Study ID Numbers: MIH_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No