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CompletedNCT07144605Updated Aug 27, 2025

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

An interventional study of CAD-CAM, indirect restorations in Molar Hypomineralization, Incisor, sponsored by Necmettin Erbakan University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
8 Years to 15 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Molar Hypomineralization, Incisor

Keywords

  • CAD-CAM, Indirect restorations
  • Molar Incisor Hypomineralization
  • MIH
03

In context

Molar Hypomineralization

121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.

This study's enrollment of 10 is below the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 198 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Voco Grandio blocs(Grandio Blocs (R) VOCO)

    Nanohybrid ceramic blocks, indirect restorative materials

    Other: CAD-CAM, indirect restorations

  • Experimental
    GC INITIAL LiSi Blocs (GC AMERICA INC. USA)

    Glass ceramic blocks, indirect restorative materials

    Other: CAD-CAM, indirect restorations

Interventions

  • OtherCAD-CAM, indirect restorations

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

06

What researchers measure

Primary outcomes

  1. the clinical status of the restorations

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

    Time frame: up to 6 months after intervention

  2. the status of the periapical tissues

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

    Time frame: Up to the 6th months

07

Study locations

1 site
  • Necmettin Erbakan University
    Konya, Meram 42090, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — The participants don't want to share the individual information about study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07144605
Lead sponsor
Necmettin Erbakan University
Responsible party
Halenur Altan (Professor, Necmettin Erbakan University) — Principal investigator
First posted
Aug 27, 2025
Start date
Jun 15, 2024
Primary completion
Jul 20, 2024
Completion
Jul 20, 2025
Last update
Aug 27, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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