Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2017-01-30

Brief Summary

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The hypothesis to be investigated is that no difference will be found upon comparing resin composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in restoring anterior primary teeth.

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Detailed Description

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The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary anterior crowns, compared with anterior resin composite strip crowns in the restoration of 120 teeth (primary incisors and lateral anterior teeth in the deciduous dentition of child patients).

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NuSmile Zirconia crowns

NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.

Group Type EXPERIMENTAL

NuSmile Zirconia crowns by NuSmile company

Intervention Type DEVICE

anterior carious teeth restored with Zirconia crowns

Composite resin strip crowns

Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.

Group Type EXPERIMENTAL

Composite resin strip crowns by 3M company

Intervention Type DEVICE

anterior carious teeth restored with Strip crowns

Interventions

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NuSmile Zirconia crowns by NuSmile company

anterior carious teeth restored with Zirconia crowns

Intervention Type DEVICE

Composite resin strip crowns by 3M company

anterior carious teeth restored with Strip crowns

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy Children with no history of any systemic illness or any developmental disease of the teeth and jaws that would have affected dietary patterns, caries, susceptibility or the selection of restorative materials to the best of current knowledge.
* Minimal of two surfaces of caries in the targeted tooth.
* Patient with Early Childhood Caries as defined by American Academy of Pediatric Dentistry (AAPD), 2016.
* Cooperative patient who had behavioral rating "positive" or "definitely positive" followed the Frankl behavior classification scale. (Frankl et al. 1962)
* Opposing teeth present.
* Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomfort, risks, and benefits.
* No patient was excluded on the basis of gender, race, social or economic background.

Exclusion Criteria

* Teeth with proximity to exfoliation and resorption of the root passed its half.
* Patients with allergy or hypersensitivity to nickel in case of posterior group teeth.
* Presence of single surface caries not involving the proximal surfaces.
* Teeth that has been subjected to trauma.
* Anxious, uncooperative patients who need to be treated under general anesthesia.
* Children who suffer from bruxism.
* Children with special needs.
* Presence of tooth wear on the opposing teeth (in case of anterior teeth), or absence of opposing.

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes