Effectiveness Of Zirconia Reinforced Glass Ionomer Used In Alternative Restorative Treatment In Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial And Finite Element Analysis)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Change in clinical success rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Test group
Intervention: zirconomer (Other)
Control
Intervention: HVGI-Equia Forte (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University