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Completed

NCT Number: NCT06456619

CAD-CAM or Adhesive Approaches for MIH Treatment

Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization.

The main questions aim to answer are:

* The clinical success rate of CAD-CAM supported restorations * The highest clinical success rate for restoring hypomineralized teeth.

Materials and method: Children aged 6-14 years old without any systemic conditions with 32 first and second hypomineralized permanent molar teeth were included in the study. Patients were randomly distributed into 2 groups as direct composite resin restorations and CAD-CAM supported inlay or onlay restorations. All restored teeth were evaluated clinically and radiographically for 24-months. Statistical significance was accepted as p<0.05.

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Key information

Conditions

Molar Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Dental Restoration Failure of Marginal Integrity Developmental Defects of Enamel Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University

Ankara, Cankaya, 06490, Turkey (Türkiye)

About this study

After randomization and local anesthesia administration, caries removal and preparation were completed under rubber-dam isolation. After preparation, 60 seconds of orthophosphoric acid, 60 seconds of 5% sodium hypochlorite and 30 seconds of orthophosphoric acid steps were applied before bonding agent and composite resin restorations. On the other hand, the preparation was completed by making a bevel on the enamel surfaces and a nanohybrid ceramic material used for the manufacturing CAD-CAM supported inlay or onlay restorations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with first and second permanent molar teeth that have loss of more than one surface due to hypomineralization and seen with white, brown, or yellow opacities on anterior permanent teeth
  • Patients without any systemic, physical, physiological, or allergic conditions

Exclusion criteria

  • Patients who had symptoms during the follow-up periods
  • Patients who did not attend follow-up appointments

Treatment and study plan

Tooth restoration

Other

Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children

Primary outcomes

  1. Clinical evaluation (Modified USPHS criteria- Anatomic form)

    Time frame: 24 months

    Anatomic form was examined by inspection at 3,6,12,18, and 24 months.

  2. Clinical evaluation (Modified USPHS criteria-Surface roughness)

    Time frame: 24 months

    Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.

  3. Clinical evaluation (Modified USPHS criteria-Marginal adaptation)

    Time frame: 24 months

    Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.

  4. Clinical evaluation (Modified USPHS criteria-Marginal discoloration)

    Time frame: 24 months

    Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.

  5. Clinical evaluation (Modified USPHS criteria-Retention)

    Time frame: 24 months

    Retention was examined by inspection and probing at 3,6,12,18, and 24 months.

  6. Clinical evaluation (Modified USPHS criteria-Color stability)

    Time frame: 24 months

    Color stability was examined by inspection at 3,6,12,18, and 24 months.

  7. Clinical evaluation (Modified USPHS criteria-Secondary caries)

    Time frame: 24 months

    Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.

  8. Clinical evaluation (Modified USPHS criteria-Proximal contact)

    Time frame: 24 months

    Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.

  9. Radiographical evaluation (Lamina dura)

    Time frame: 24 months

    Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

  10. Radiographical evaluation (Change in inter-root trabeculation continuity)

    Time frame: 24 months

    Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

  11. Radiographical evaluation (Radiolucent area development)

    Time frame: 24 months

    Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Composite Resin Restorations and Computer-Aided Restorations in Young Permanent Molar Teeth With Molar Incisor Hypomineralization

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

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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