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

NCT ID: NCT07144605

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-07-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Molar Hypomineralization, Incisor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In our study, treatment was planned for moderately affected teeth according to the MIH Severity Index. The study was designed as a prospective, randomized, split-mouth trial. Group randomization was performed using the sealed envelope technique. In the same patient, VOCO GrandioBloc (VOCO GmbH, Cuxhaven, Germany) was applied to one tooth, while a GC Initial lithium disilicate block was applied to the symmetrical contralateral tooth.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Voco Grandio blocs(Grandio Blocs (R) VOCO)

Nanohybrid ceramic blocks, indirect restorative materials

Group Type EXPERIMENTAL

CAD-CAM, indirect restorations

Intervention Type OTHER

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

GC INITIAL LiSi Blocs (GC AMERICA INC. USA)

Glass ceramic blocks, indirect restorative materials

Group Type EXPERIMENTAL

CAD-CAM, indirect restorations

Intervention Type OTHER

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

Interventions

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CAD-CAM, indirect restorations

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Halenur Altan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://link.springer.com/article/10.1007/s10266-023-00841-w

https://link.springer.com/article/10.1007/s10266-023-00841-w

Other Identifiers

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NecmettinEU05

Identifier Type: -

Identifier Source: org_study_id

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