Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: NuSmile Zirconia crowns by NuSmile company; Device: Composite resin strip crowns by 3M company

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NuSmile Zirconia crowns; NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.	Device: NuSmile Zirconia crowns by NuSmile company; anterior carious teeth restored with Zirconia crowns
EXPERIMENTAL: Composite resin strip crowns; 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; anterior carious teeth restored with Strip crowns

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Bashaer S Abdulhadi, MSc, King Abdulaziz University

Publications and helpful links

General Publications

• Alaki SM, Abdulhadi BS, AbdElBaki MA, Alamoudi NM. Comparing zirconia to anterior strip crowns in primary anterior teeth in children: a randomized clinical trial. BMC Oral Health. 2020 Nov 10;20(1):313. doi: 10.1186/s12903-020-01305-1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): January 30, 2017

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (ACTUAL): June 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: caries; crown; full coverage; strip crown; Zirconia crown; primary anterior teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: King AbdulAziz University (Other Identifier: King AbdulAziz University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes