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Clinical Trials/NCT06456619
NCT06456619
Completed
Not Applicable

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

Baskent University1 site in 1 country22 target enrollmentJanuary 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Molar Hypomineralization
Sponsor
Baskent University
Enrollment
22
Locations
1
Primary Endpoint
Clinical evaluation (Modified USPHS criteria-Surface roughness)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
February 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

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.

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.

Radiographical evaluation (Lamina dura)

Time Frame: 24 months

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

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.

Study Sites (1)

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