Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

King Abdulaziz University120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Dental Caries

Interventions

NuSmile Zirconia crowns by NuSmile companyDEVICE

anterior carious teeth restored with Zirconia crowns

Composite resin strip crowns by 3M companyDEVICE

anterior carious teeth restored with Strip crowns

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 \[Löe, 1967\].

Time frame: 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 \[Löe,1967\].

Time frame: 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 \[Ryge, 1980\].

Time frame: 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)

Time frame: 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 \[Löe, 1967\].

Time frame: 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 \[Löe, 1967\].

Time frame: 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 \[Ryge, 1980\].

Data from ClinicalTrials.gov

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