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Clinical Trials/NCT05034003
NCT05034003
Completed
Not Applicable

Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors

Hacettepe University1 site in 1 country25 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries in Children
Sponsor
Hacettepe University
Enrollment
25
Locations
1
Primary Endpoint
Number of zirconia and composite strip crowns that showed successful retention over two years
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
January 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zafer Cavit Cehreli, DDS, PhD

Prof.Dr.

Hacettepe University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Number of zirconia and composite strip crowns that showed successful retention over two years

Time Frame: 2 years

Long-term clinical success of zirconia and composite strip crowns placed on primary incisors

Study Sites (1)

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