CAD-CAM or Adhesive Approaches for MIH Treatment

NCT ID: NCT06456619

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2024-02-15

Brief Summary

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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

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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.

Conditions

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Molar Hypomineralization Dental Restoration Failure of Marginal Integrity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Observational clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tooth restoration

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Tooth restoration

Intervention Type OTHER

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

Interventions

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Tooth restoration

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didem Sakaryalı Uyar, PhD MD, DDS

Role: PRINCIPAL_INVESTIGATOR

Başkent Universiry

Locations

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Başkent University

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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D-KA19/04

Identifier Type: -

Identifier Source: org_study_id

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