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Clinical Performance of Restorations in Teeth Affected by Molar Incisor Hypomineralization

Clinical Performance of Glass Ionomer and Composite Restorations in First Permanent Molars Affected by Molar Incisor Hypomineralization

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07733804
Enrollment
31
Registered
2026-07-29
Start date
2020-04-01
Completion date
2020-08-01
Last updated
2026-07-29

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

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor hypomineralization, glass hybrid, short fiber reinforced composite

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).

Detailed description

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: 1. Cooperative children 2. Good oral hygiene, no periodontal disease or bad habits, 3. Presence of at least two permanent molars with MIH involving dentin with 31 split-mouth design study according to the clinical and radiological examination. 4. Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact 5. According to the split mouth working design, an equal number of teeth were selected from the right and left sides. The exclusion criteria were; 1. History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials. 2. Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded

Interventions

PROCEDURERestoration 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.

PROCEDURERestoration with Glass Hybrid Restorative Material (EQUIA Forte HT)

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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Split-mouth

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service CriteriaBaseline and 12, 24, 36, and 60 months after restoration placementThe 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.
Restoration SurvivalBaseline and 12, 24, 36, and 60 months after restoration placementRestoration 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026