Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

Study Overview
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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.

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).

Official Title
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Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns

Conditions
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Dental Caries

Intervention / Treatment
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* Device: NuSmile Zirconia crowns by NuSmile company
* Device: Composite resin strip crowns by 3M company


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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
Interventional Model Description: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuSmile Zirconia crowns<br>NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth. | Device: NuSmile Zirconia crowns by NuSmile company<br>* anterior carious teeth restored with Zirconia crowns<br>|
| Experimental: Composite resin strip crowns<br>Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth. | Device: Composite resin strip crowns by 3M company<br>* anterior carious teeth restored with Strip crowns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Health | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967]. | 3-month follow-up | 
| Plaque index | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe,1967]. | 3-month follow-up | 
| Restoration failure | This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service USPHS, Alpha criteria rating system [Ryge, 1980]. | 3-month follow-up | 
| Tooth wear of opposing dentition | Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984) | 3-month follow-up | 
| Gingival Health | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967]. | 6-month follow-up | 
| Plaque index | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967]. | 6-month follow-up | 
| Restoration failure | This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service USPHS, Alpha criteria rating system [Ryge, 1980]. | 6-month follow-up | 
| Tooth wear of opposing dentition | Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984) | 6-month follow-up | 
| Gingival Health | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967]. | 12-month follow-up | 
| Plaque index | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967]. | 12-month follow-up | 
| Restoration failure | This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service USPHS, Alpha criteria rating system [Ryge, 1980]. | 12-month follow-up | 
| Tooth wear of opposing dentition | Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984) | 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, crown, full coverage, strip crown, Zirconia crown, primary anterior teeth