CAD-CAM or Adhesive Approaches for MIH Treatment

June 7, 2024 updated by: Baskent University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06490
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Composite resin (Filtek Z250, 3M ESPE)
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.
Other: Tooth restoration
Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children
Experimental: CAD-CAM supported (Cerasmart, GC Dental)
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.
Other: Tooth restoration
Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Principal Investigator: Didem Sakaryalı Uyar, PhD MD, DDS, Başkent Universiry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-KA19/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Information about patients might be requested from the principal author due to reasonable cause.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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