Clinical Performance of Restorations in Teeth Affected by Molar Incisor Hypomineralization

NCT07733804 | Completed

• 1 other identifier: MIH_SFRC
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor hypomineralization; glass hybrid; short fiber reinforced composite

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 12, 24, 36, and 60 months after restoration placement

Study Arms (2)

glass hybrid

ACTIVE COMPARATOR

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)

short fiber reinforced composite (SFRC)

ACTIVE COMPARATOR

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)

Interventions

Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior) PROCEDURE

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.

short fiber reinforced composite (SFRC)

Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT) PROCEDURE

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.

glass hybrid

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative children.
• Good oral hygiene, no periodontal disease or bad habits.
• The presence of at least two permanent molars with MIH involving dentin with a split-mouth design study according to the clinical and radiological examination.
• Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact.
• According to the split mouth working design, an equal number of teeth were selected from the right and left sides.

You may not qualify if:

• History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials.
• Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry Department of Pediatric Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: July 29, 2026
• Study Start: April 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)