Skip to main content
OpenTrials
Completed

NCT Number: NCT05034003

Success 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconia crown

Device

Esthetic crowns for capping primary incisor with caries

Composite strip crown

Device

Esthetic resin restoration for primary incisor with caries

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.