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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05494749
Other study ID # MIH_2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Enrolling by invitation NCT03233464 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate N/A
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