Back to resultsZirconia Reinforced Glass Ionomer in MIH
Primary Purpose
Molar Incisor Hypomineralization
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
zirconomer
HVGI-Equia Forte
Sponsored by
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralization
Eligibility Criteria
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
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05494749
First Posted
August 8, 2022
Last Updated
December 22, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05494749
Brief Title
Zirconia Reinforced Glass Ionomer in MIH
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
zirconomer
Intervention Description
teeth meeting the inclusion criteria are assigned to receive Zirconomer® restorations
Intervention Type
Other
Intervention Name(s)
HVGI-Equia Forte
Intervention Description
teeth meeting the inclusion criteria are assigned to receive HVGI-Equia Forte® restorations.
Primary Outcome Measure Information:
Title
Change in clinical success rate
Description
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.
Time Frame
at 3 months, 6 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
Change in pain
Description
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.
Time Frame
at 1 week, 3 months, 6 months, 9 months, 12 months
Title
Change in sensitivity
Description
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.
Time Frame
at 1 week, 3 months, 6 months, 9 months, 12 months
Title
Finite element analysis
Description
Performance of both Zirconomer and HVGI-Equia Forte under dynamic occlusal loads will be assessed using Finite Element Analysis using ANSYS software.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham A Mahfouz, MSc
Organizational Affiliation
Alexandria University, Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Zirconia Reinforced Glass Ionomer in MIH
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