Zirconia Reinforced Glass Ionomer in MIH

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494749
• Other study ID #: MIH_2022
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Other:
• zirconomer
teeth meeting the inclusion criteria are assigned to receive Zirconomer® restorations
• HVGI-Equia Forte
teeth meeting the inclusion criteria are assigned to receive HVGI-Equia Forte® restorations.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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