Zirconia Reinforced Glass Ionomer in MIH

NCT05494749 | Completed

• 1 other identifier: MIH_2022
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in pain

  at 1 week, 3 months, 6 months, 9 months, 12 months

• Change in sensitivity

  at 1 week, 3 months, 6 months, 9 months, 12 months

• Finite element analysis

  12 months

Study Arms (2)

Test group

EXPERIMENTAL

Other: zirconomer

Control

ACTIVE COMPARATOR

Other: HVGI-Equia Forte

Interventions

zirconomer OTHER

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

Test group

HVGI-Equia Forte OTHER

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

Control

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (1)

• Mahfouz RA, Hanno AG, Rahman AMAE. Zirconia-reinforced glass ionomer restorations in molar incisor hypomineralization: a randomized controlled clinical trial. Clin Oral Investig. 2025 May 8;29(6):290. doi: 10.1007/s00784-025-06352-y.

  PMID: 40335753 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Reham A Mahfouz, MSc

  Alexandria University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: September 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)