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A study in children comparing three tooth-colored filling materials for weak enamel (MIH) in molar teeth and how well they last over time.

Comparative Evaluation of Resin Modified, Zirconia-Reinforced, and Hydroxyapatite-Reinforced Glass Ionomer Restorations In MIH-Affected Permanent Molars: A Randomised Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109224
Enrollment
90
Registered
2026-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: Glass Ionomer Cement Restorations: Following standard cavity preparation, the operative field will be isolated using a rubber dam to ensure a dry and contamination-free environment. The

Sponsors

Dr Vanshika Sethi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in the age group 6-12 years. 2. Patients who are diagnosed with mild to moderate MIH according to EAPD criteria. 3. MIH affected molars with MIH-TNI scoring (2a), 2b), (4a), or (4b) (W rzburg). 4. Carious molars scoring 5 or 6 on the ICDAS II. 5. Children with Frankl behavior score 3 or 4. 6. Children fit under ASA I. 7. Patients who will provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Children having Enamel defects due to a condition other than MIH. 2. Patients who presented with non-restorable permanent first molars or those indicated for extraction, or having fixed orthodontic appliances. 3. Children with Frankl behavior score 1 or 2. 4. Medically compromised children (ASA II, III, IV, V, VI).

Design outcomes

Primary

MeasureTime frame
The expected outcome is-Hydroxyapatite-reinforced GIC is anticipated to demonstrate improved marginal integrity, reduced postoperative sensitivity, and better resistance to post-eruptive enamel breakdown due to its bioactive properties. Zirconia-reinforced GIC is expected to show superior mechanical strength, while RMGIC may provide reliable adhesion and fluoride release but comparatively lower durability in stress-bearing areas.Timepoint: All subjects will be evaluated at predetermined intervals at baseline (pre- operatively), 1st week, 3rd month, 6th month, 9th month and 12th month. All evaluations will be carried out under standardized clinical conditions to ensure consistency and reliability of the recorded data.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Vanshika Sethi

Rungta College of Dental Sciences and Research

drlumbinip@gmail.com7830008831

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026