An interventional study of Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior) and Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT) in Molar Incisor Hypomineralization, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
This study evaluated the clinical performances of a glass hybrid restoration and direct posterior micro-hybrid composite restorations with short fiber reinforced composite (SFRC) after Selective Caries Removal in restorations of first permanent molars (FPMs) that were affected by Molar Incisor Hypomineralization (MIH).
This study is being carried out in the Department of Pediatric Dentistry, Dental School, Marmara University in Türkiye. The study reviewed and approved by The Human Research Ethics Committee of Marmara University, Dental School with the protocol number of 2019-355. Informed consent forms were obtained from parents or guardians before the child participated in the study.
Study design: A split-mouth, randomized, controlled clinical study was done. The children who were diagnosed with MIH on the basis of clinical examination at the Pediatric Dentistry Clinics of Dental School, Marmara University, Turkey were enrolled in the study. No children were excluded based on gender, social or economic status.
The inclusion criteria were:
The exclusion criteria were;
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Exclusion Criteria:
Isolation was maintained using cotton rolls and a saliva ejector. MIH lesions were restored with Equia Forte HT (GC Corporation, Europe) according to manufacturer's orders. For mixing the encapsulated Equia Forte HT Bulk Fill Glass Hybrid, Capsule Mixer CM-II (GC Europe) was used for 10 sec under +/- 4,000RPM. The automatically mixed study material (10 s) was slowly injected into the cavity. The overflowing excesses were cleaned by hand tools. After 45 sec the restoration material was formed into shape. After a 2.5-min setting time, the occlusion was checked using fine carbon paper and then adjusted. Equia Coat (GC) was applied and light cured for 20 s (D-Light Duo, GC, 1,400 mW/cm2 ). After finishing the restoration procedure, the children were instructed not to eat for at least 1 h.
Procedure: Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT)
Teeth were restored as same protocol with micro-hybrid composite (G-aenial, GC, Europe). LED light (GC- D-Light) was used at standard mode 1400 mW/cm2, at 50-60 ºC, for 20 sec. Immediately after heat application, occlusal interferences were checked. The restorations were trimmed and adapted using high-speed, water-cooled fine diamond burs (125 μm, Intensiv SA, Switzerland),) than polished after the estimated setting time.
Procedure: Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior)
Following selective caries removal, the cavity was restored with a short fiber-reinforced flowable composite (EverX Flow) as a dentin replacement, followed by placement of a conventional microhybrid composite resin (G-ænial Posterior) as the occlusal enamel replacement.
Following selective caries removal, the cavity was restored with a glass hybrid restorative material (EQUIA Forte HT). After finishing and polishing, a light-cured resin coating (EQUIA Forte Coat) was applied to the restoration.
Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria
The clinical performance of the restorations will be evaluated using the modified United States Public Health Service (USPHS) criteria, including retention, marginal adaptation, marginal discoloration, anatomical form, color match, secondary caries, and postoperative sensitivity. Each criterion will be rated as Alpha, Bravo, or Charlie, with Alpha indicating the best clinical outcome and Charlie indicating an unacceptable outcome or restoration failure. For most criteria, Alpha and Bravo ratings will be considered clinically satisfactory, whereas Charlie ratings will be considered clinically unsatisfactory. For secondary caries, Alpha indicates the absence of caries and Bravo indicates the presence of secondary caries.
Time frame: Baseline and 12, 24, 36, and 60 months after restoration placement
Restoration Survival
Restoration survival will be assessed at each follow-up visit (12, 24, 36, and 60 months after restoration placement) using Kaplan-Meier survival analysis. A restoration will be considered to have survived if it remains clinically functional without requiring replacement. Survival probabilities will be estimated using the Kaplan-Meier method and compared between groups using the log-rank test.
Time frame: Baseline and 12, 24, 36, and 60 months after restoration placement
Plan to share: No
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