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Completed

NCT Number: NCT05494749

Zirconia Reinforced Glass Ionomer in MIH

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

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Key information

Conditions

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

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zirconomer

Other

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

HVGI-Equia Forte

Other

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

Primary outcomes

  1. Change in clinical success rate

    Time frame: 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 outcomes

  1. Change in pain

    Time frame: 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.

  2. Change in sensitivity

    Time frame: 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.

  3. Finite element analysis

    Time frame: 12 months

    Performance of both Zirconomer and HVGI-Equia Forte under dynamic occlusal loads will be assessed using Finite Element Analysis using ANSYS software.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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