Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Composite resin strip crowns by 3M company; Device: NuSmile Zirconia crowns by NuSmile company

• Registration Number: NCT03184012
• Lead Sponsor: King Abdulaziz University

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-11-01
• Primary Completion: 2016-11-01
• Study Completion: 2017-01-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Composite resin strip crowns	Composite resin strip crowns by 3M company	Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.
NuSmile Zirconia crowns	NuSmile Zirconia crowns by NuSmile company	NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.

Primary Outcome Measures

Name	Time	Method
Gingival Health	12-month follow-up	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 \[Löe, 1967\].
Plaque index	12-month follow-up	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 \[Löe, 1967\].
Restoration failure	12-month follow-up	This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system \[Ryge, 1980\].
Tooth wear of opposing dentition	12-month follow-up	Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)