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Success of Zirconia and Composite Strip Crowns for Primary Incisors

Primary Purpose

Dental Caries in Children

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Zirconia crown
composite strip crown
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring zirconia crowns, composite strip crowns, dental caries

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

zirconia crowns

composite strip crowns

Control tooth

Arm Description

Zirconia crowns placed on primary incisor teeth

composite strip crowns placed on primary incisor teeth

Caries-free primary incisor tooth

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2021
Last Updated
April 6, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05034003
Brief Title
Success of Zirconia and Composite Strip Crowns for Primary Incisors
Official Title
Clinical and Radiographic Performance of Zirconia and Composite Strip Crowns for Primary Incisors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
zirconia crowns, composite strip crowns, dental caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zirconia crowns
Arm Type
Experimental
Arm Description
Zirconia crowns placed on primary incisor teeth
Arm Title
composite strip crowns
Arm Type
Experimental
Arm Description
composite strip crowns placed on primary incisor teeth
Arm Title
Control tooth
Arm Type
No Intervention
Arm Description
Caries-free primary incisor tooth
Intervention Type
Device
Intervention Name(s)
Zirconia crown
Intervention Description
Esthetic crowns for capping primary incisor with caries
Intervention Type
Device
Intervention Name(s)
composite strip crown
Intervention Description
Esthetic resin restoration for primary incisor with caries
Primary Outcome Measure Information:
Title
Number of zirconia and composite strip crowns that showed successful retention over two years
Description
Long-term clinical success of zirconia and composite strip crowns placed on primary incisors
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zafer c cehreli
Organizational Affiliation
Hacettepe university , Faculty of dentistry, ankara/Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Success of Zirconia and Composite Strip Crowns for Primary Incisors

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