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Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With Molar-Incisor Hypomineralisation

NCT06987448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-21

No results posted yet for this study

Summary

This clinical study was conducted to compare two different dental materials used in the treatment of children who have a condition called molar-incisor hypomineralization (MIH). MIH affects the quality of the enamel in permanent molars and can cause sensitivity, pain, and rapid tooth breakdown. In this study, children between the ages of 8 and 13 who had MIH in at least two molars received two types of onlay restorations: one made from a hybrid composite block and the other from a hybrid ceramic block. Both restorations were designed and manufactured using a digital system called CAD/CAM, which allows for more precise and efficient dental treatment.

Each child received both types of restorations-one on each side of the mouth-in a split-mouth design. The goal was to see how well each material worked over a period of six months. The restorations were evaluated by trained dentists using clinical criteria, and the children were also assessed for tooth sensitivity using a cold air test.

The main purpose of this study was to find out which material provides better clinical performance and reduces tooth sensitivity more effectively.

Conditions

  • Enamel Hypoplasia
  • Molar-Incisor Hypomineralization (MIH)
  • Restoration of Permanent Molars Affected by MIH With CAD/CAM Blocks

Interventions

PROCEDURE

Semi-direct onlay restoration using CAD/CAM hybrid composite block

This refers to restorations fabricated from nano-ceramic hybrid composite blocks via chairside CAD/CAM workflow and cemented to permanent molars affected by MIH (molar-incisor hypomineralization).

PROCEDURE

Semi-direct onlay restoration using CAD/CAM hybrid ceramic block

This refers to restorations fabricated from polymer-infiltrated hybrid ceramic blocks using a digital workflow, then cemented to MIH-affected permanent molars.

Sponsors & Collaborators

  • Marmara University

    collaborator OTHER

  • Alp Akça

    lead OTHER

Principal Investigators

  • Alp Akça, Doctor of Dental Surgery (DDS) · Marmara University, School of Dentistry, Department of Pediatric Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2024-03-15
Completion
2025-09-11

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06987448 on ClinicalTrials.gov