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CAD-CAM or Adhesive Approaches for MIH Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06456619
Enrollment
22
Registered
2024-06-13
Start date
2020-01-15
Completion date
2024-02-15
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure of Marginal Integrity, Molar Hypomineralization

Keywords

Molar incisor hypomineralization, CAD-CAM supported restoration, Composite resin restoration

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Observational clinical trial

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical evaluation (Modified USPHS criteria- Anatomic form)24 monthsAnatomic form was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Surface roughness)24 monthsSurface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal adaptation)24 monthsMarginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal discoloration)24 monthsMarginal discoloration was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Retention)24 monthsRetention was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Color stability)24 monthsColor stability was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Secondary caries)24 monthsSecondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Proximal contact)24 monthsProximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.
Radiographical evaluation (Lamina dura)24 monthsLamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Radiographical evaluation (Change in inter-root trabeculation continuity)24 monthsChange in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Radiographical evaluation (Radiolucent area development)24 monthsRadiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026