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

NCT07144605 | Completed DMC

• 1 other identifier: NecmettinEU05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molar Hypomineralization, Incisor

Keywords

CAD-CAM, Indirect restorations; Molar Incisor Hypomineralization; MIH

Outcome Measures

Primary Outcomes (2)

• the clinical status of the restorations

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

  up to 6 months after intervention

• the status of the periapical tissues

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

  Up to the 6th months

Study Arms (2)

Voco Grandio blocs(Grandio Blocs (R) VOCO)

EXPERIMENTAL

Nanohybrid ceramic blocks, indirect restorative materials

Other: CAD-CAM, indirect restorations

GC INITIAL LiSi Blocs (GC AMERICA INC. USA)

EXPERIMENTAL

Glass ceramic blocks, indirect restorative materials

Other: CAD-CAM, indirect restorations

Interventions

CAD-CAM, indirect restorations 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); Voco Grandio blocs(Grandio Blocs (R) VOCO)

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 27, 2025
• Study Start: June 15, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)