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IRCT20250209064689N2 IRCT 2026-06-11 Esfahan University of Medical Sciences Evaluation of the results of silver-modified atraumatic restorative treatment (SMART) compared with conventional preventive resin restoration (PRR) in hypomineralized molars (MIH) with early carious lesions: a randomized clinical trial Comparative study of the results of silver-modified atraumatic restorative treatment (SMART) and preventive resin restoration (PRR) in hypomineralized molars (MIH) with early carious lesions: a randomized clinical trial 2026-05-21 anticipated 28 Complete https://irct.ir/trial/89860 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using a random number table and maintained in sealed envelopes by the study supervisor. 3 Molar-Incisor Hypomineralization. Intervention 1: First intervention group: PRR technique, where initially, surface careis are removed using a small, pear-shaped or rounded end burr under high-speed handpiece cooling with continuous water. The pit and fissures are etched for 20 seconds with 37% phosphoric acid gel (Vococid, Voco, Cuxhaven, Germany) and then rinsed with water, dried, and bonded (Voco, Cuxhaven, Germany) applied, and the tooth is cured for 20 seconds. Finally, the prepared cavity is restored and cured with composite flow (Grandio Shade A2, Voco, Cuxhaven, Germany). Intervention 2: Second intervention group: SMART technique, where SDF 38% (Cariestop, Biodinamica Quimica E Farmaceutica, Ibipora, Parana, Brazil) is applied as follows: SDF vial is applied to the entire surface of the tooth using a brush. The tooth is dried with cotton balls and then, to minimize the risk of color change, GIC (Riva Light Cure HV, SDI, Bayswater, Australia) is injected into the pits and fissures one week later and cured for 20 seconds. Finally, excess material is quickly removed and the occlusion is examined and adjusted. Yes - There is a plan to make this available What will be shared: All data potentially can be shared after de-identifying individuals When: The start of the access period is one month after the results are published. To whom: Researchers employed in academic and scientific institutions Conditions: For use in related research and healthcare services Where to obtain: N.ahmadi3731@gmail.com How to obtain: After requesting via email, the necessary reviews will be conducted and the research-related files will be made available to him. Comments:
public Nayereh Ahmadi
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5539 N.ahmadi3731@gmail.com Esfahan University of Medical Sciences scientific Narjes Amrollahi Biyuki
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5539 n_amrollahi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children aged 6 to 13 years with at least two fully erupted permanent first molars and MIH with treatment need score of 1 and 3 (based on European Academy of Paediatric Dentistry (EAPD) criteria) Dental caries with code 1 or 2 according to the International Caries Detection and Assessment System (ICDAS II) Absence of any systemic disease (ASA I) 6 years 13 years Both Treatment - Devices Treatment - Devices First intervention group: PRR technique, where initially, surface careis are removed using a small, pear-shaped or rounded end burr under high-speed handpiece cooling with continuous water. The pit and fissures are etched for 20 seconds with 37% phosphoric acid gel (Vococid, Voco, Cuxhaven, Germany) and then rinsed with water, dried, and bonded (Voco, Cuxhaven, Germany) applied, and the tooth is cured for 20 seconds. Finally, the prepared cavity is restored and cured with composite flow (Grandio Shade A2, Voco, Cuxhaven, Germany). Second intervention group: SMART technique, where SDF 38% (Cariestop, Biodinamica Quimica E Farmaceutica, Ibipora, Parana, Brazil) is applied as follows: SDF vial is applied to the entire surface of the tooth using a brush. The tooth is dried with cotton balls and then, to minimize the risk of color change, GIC (Riva Light Cure HV, SDI, Bayswater, Australia) is injected into the pits and fissures one week later and cured for 20 seconds. Finally, excess material is quickly removed and the occlusion is examined and adjusted. Marginal fit of the repairing material used based on the modified clinical ranking system of the United States Public Health Service (MUSPHS). Timepoint: Initially and subsequently in the months of 1 and 6 after treatment. Method of measurement: Modified Clinical Ranking System of the U.S. Public Health Service (MUSPHS). Retention of the repairing material used based on the modified clinical ranking system of the United States Public Health Service (MUSPHS). Timepoint: Initially and subsequently in the months of 1 and 6 after treatment. Method of measurement: Modified Clinical Ranking System of the U.S. Public Health Service (MUSPHS). Recurrent caries of the repairing material used based on the modified clinical ranking system of the United States Public Health Service (MUSPHS). Timepoint: Initially and subsequently in the months of 1 and 6 after treatment. Method of measurement: Modified Clinical Ranking System of the U.S. Public Health Service (MUSPHS). Marginal discoloration of the repairing material used based on the modified clinical ranking system of the United States Public Health Service (MUSPHS). Timepoint: Initially and subsequently in the months of 1 and 6 after treatment. Method of measurement: Modified Clinical Ranking System of the U.S. Public Health Service (MUSPHS). Esfahan University of Medical Sciences Approved 2026-01-13 Ethics committee of Isfahan University of Medical Sciences Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)