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OpenTrials
Completed

NCT Number: NCT07144605

Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study

This study is about the long-term survival success of different, externally prepared fillings (Indirect restoration, CAD-CAM blocks) used in teeth with reduced mineral structure, namely Molar Incisor Hypomineralization (MIH), which is called chalk teeth in children.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

About this study

The aim of this study was to comparatively evaluate the long-term survival times and clinical success of nano-ceramic hybrid CAD-CAM blocks, Grandio Blocs (R) (VOCO), and glass-ceramic blocks, GC INITIAL LiSi (GC AMERICA INC. USA), according to USPHS criteria, after pulpal treatment in mandibular teeth with bilateral moderate molar incisor hypomineralization.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

8-15 years old

  • Systemically healthy
  • Cooperative (Frankl 3-4)
  • Diagnosed with MIH for at least one permanent tooth
  • Symmetrical mandibular molars that fit the middle MIH classification (teeth with a tooth score of 7-9 in MIHSI)
  • Teeth without indication for root canal treatment
  • Teeth without percussion, abscess and fistula formation
  • Without periapical lesions
  • With post-eruption enamel fractures in the relevant teeth
  • Without mobility and pathological gingival pockets
  • Patients who agreed to participate in the study.

Exclusion criteria

Teeth that are suitable for mild and severe classification

  • Non-cooperative (Frankl 1 and Frankl 2)
  • Teeth with extraction indication
  • Teeth that require root canal treatment
  • Teeth with periapical lesions, abscesses and fistula formation
  • Patients with mobility and pathological gingival pockets

Treatment and study plan

CAD-CAM, indirect restorations

Other

Indirect restorations that we think will last longer than traditional filling materials in teeth with molar hypomineralization.

Primary outcomes

  1. the clinical status of the restorations

    Time frame: up to 6 months after intervention

    The restorations were clinically evaluated in the oral cavity using the USPHS index.

  2. the status of the periapical tissues

    Time frame: Up to the 6th months

    The periapical tissue status was assessed according to the Periapical Index (PAI).

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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