Zirconia Reinforced Glass Ionomer in MIH

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization
• Interventions: Other: zirconomer; Other: HVGI-Equia Forte

• Registration Number: NCT05494749
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	zirconomer	-
Control	HVGI-Equia Forte	-

Primary Outcome Measures

Name	Time	Method
Change in clinical success rate	at 3 months, 6 months, 9 months, 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in pain	at 1 week, 3 months, 6 months, 9 months, 12 months	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.
Change in sensitivity	at 1 week, 3 months, 6 months, 9 months, 12 months	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.
Finite element analysis	12 months	Performance of both Zirconomer and HVGI-Equia Forte under dynamic occlusal loads will be assessed using Finite Element Analysis using ANSYS software.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt