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CAD-CAM or Adhesive Approaches for MIH Treatment

B

Baskent University

Status

Completed

Conditions

Dental Restoration Failure of Marginal Integrity
Molar Hypomineralization

Treatments

Other: Tooth restoration

Study type

Interventional

Funder types

Other

Identifiers

NCT06456619
D-KA19/04

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

6 to 14 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Composite resin (Filtek Z250, 3M ESPE)
Active Comparator group
Description:
A pretreatment protocol including sodium hypochlorite and ortho-phosphoric acid was applied to the tooth surface. Then, the tooth was restored with a composite resin material (Filtek Z250, 3M ESPE). This protocol is a clinically approved way for restoring hypomineralized teeth.
Treatment:
Other: Tooth restoration
CAD-CAM supported (Cerasmart, GC Dental)
Experimental group
Description:
The preparation was completed by making bevels on the enamel surfaces. Then, an intraoral impression was taken to sent to the laboratory for manufacturing CAD-CAM-supported restoration with a nanohybrid ceramic material (Cerasmart, GC Dental). CAD-CAM supported restorations can be done by using a lot of restorative blocks by milling them. In this study, we preferred using resin-based blocks (Cerasmart, GC Dental) to compare with the control group.
Treatment:
Other: Tooth restoration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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