Success of Zirconia and Composite Strip Crowns for Primary Incisors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors

Detailed Description
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Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. A caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type. Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments. The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

Official Title
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Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Device: Zirconia crown
* Device: composite strip crown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients and parent of the patients who accept to participate and sign the informed consent Patients who have at least two primary maxillary incisor with caries that require crown restoration Teeth that have healthy lamina dura and periodontal ligament Teeth with no mobility and enough root length Patients that have good cooperation to the procedure Exclusion Criteria: Patients and parent of the patients who don't accept to participate and sign the informed consent Teeth that are previously restored Patients who are uncooperative Teeth that doesn't have opposing primary incisors Patients who have bruxism or deep-bite Teeth that are close to be erupted Teeth that have vital or non-vital pulp therapy

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zirconia crowns<br>Zirconia crowns placed on primary incisor teeth | Device: Zirconia crown<br>* Esthetic crowns for capping primary incisor with caries<br>|
| Experimental: composite strip crowns<br>composite strip crowns placed on primary incisor teeth | Device: composite strip crown<br>* Esthetic resin restoration for primary incisor with caries<br>|
| No Intervention: Control tooth<br>Caries-free primary incisor tooth | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of zirconia and composite strip crowns that showed successful retention over two years | Long-term clinical success of zirconia and composite strip crowns placed on primary incisors | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zirconia crowns, composite strip crowns, dental caries