Success of Zirconia and Composite Strip Crowns for Primary Incisors

Not Applicable

Completed

• Conditions: Dental Caries in Children
• Interventions: Device: Zirconia crown; Device: composite strip crown

• Registration Number: NCT05034003
• Lead Sponsor: Hacettepe University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2021-08-01
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-05
• Study Completion: 2022-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zirconia crowns	Zirconia crown	Zirconia crowns placed on primary incisor teeth
composite strip crowns	composite strip crown	composite strip crowns placed on primary incisor teeth

Primary Outcome Measures

Name	Time	Method
Number of zirconia and composite strip crowns that showed successful retention over two years	2 years	Long-term clinical success of zirconia and composite strip crowns placed on primary incisors

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey