Success of Zirconia and Composite Strip Crowns for Primary Incisors

April 6, 2023 updated by: Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zirconia crowns
Zirconia crowns placed on primary incisor teeth
Device: Zirconia crown
Esthetic crowns for capping primary incisor with caries
Experimental: composite strip crowns
composite strip crowns placed on primary incisor teeth
Device: composite strip crown
Esthetic resin restoration for primary incisor with caries
No Intervention: Control tooth
Caries-free primary incisor tooth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: zafer c cehreli, Hacettepe university , Faculty of dentistry, ankara/Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anterior crown rest

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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