Can Zirconia Crown be the First Choice for Primary Teeth?

February 20, 2023 updated by: Zeynep Aslı GÜÇLÜ, TC Erciyes University

Can Zirconia Crown be the First Restorative Choice After Endodontic Treatment for Primary Teeth?

Objective: Early loss of primary teeth due to caries, can cause occlusion disorders, aesthetic problems, nutritional problems, abnormal language habits, speech disorders and psychological problems temporary or permanent. The purpose of this study was to evaluate the success of using prefabricated aesthetic crowns for the restoration of excessive tooth loss.

Study design: In this randomized, non-blinded clinical study a total of 45 teeth were included, primary molars and anterior teeth and requiring restoration after root canal treatment. Stainless steel(SCC), zirconia(ZC) and strip(S) crowns compared clinically, radiographically and periodontally during follow up period for 6 months. Parents were asked to fill out questionnaire at the 1st and 6th months to evaluate the satisfaction level. In addition, patients' pain and discomfort level was assessed using the visual analogue scale (VAS) scale.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The color of crowns made it impossible to blind during clinical assessment. Thus, this study was a non-blinded, randomised, and prospective clinical trial.

Sample size: This study included 20 maxillary anterior and 25 posterior teeth that required restoration due to excessive material loss. The study groups were:

Zirconia crown(ZC) restoration on the primary central and lateral tooth with root canal treatment (n = 10), strip crown(S) restoration on the primary central and lateral tooth with root canal treatment (n = 10), Zirconia crown(ZC) restoration on primary teeth with root canal treatment (n = 12), Stainless-steel crown(SSC) restoration on primary teeth with root canal treatment (n = 13).

Clinical Procedure:

Assessment

Clinical assesment: Table 1 Gingival scores: Löe and Silness Gingival Index(GI)[Löe, 1967].

Periapical radiographic evaluation: Preoperative and every follow up visit. (Radiographic assesment: Table 2)

Intraoral photos (standard method): before treatment, after treatment and at every follow-up visit.

Crown restoration: All caries were removed after administration of local anaesthesia and proper isolation. Calcium hydroxide/iodoform paste (Vitapex®) pulpectomy was performed according to the guideline. Teeth were restored with a composite resin Nova Resin (IMICRYL®, Konya, Turkey) and glass ionomer cement (MERON®, Voco, Germany) was used as a base material. Strip Crown Forms (3M-ESPE, St. Paul,Minnesota, USA) were used to restore teeth group SC. ZC group (NuSmile, Houston, Tex. the USA) and SCC(3M ESPE, Minnesota, USA) used.

Visual analogue scale(VAS): 0-2: no pain/discomfort 4-6:moderate 8-10: high pain/discomfort.

The child was asked to choose his/her feelings about the tooth after the procedure and in follow-up appointments. Parents were asked to complete their satisfaction surveys, including the post-op and 6-month controls for patient satisfaction assessment.

Statistical Method:

IBM® SPSS® Statistics V23 analysed data. The Mann-Whitney U and Chi-square tests were used for intergroup comparisons within the anterior and posterior regions. The Friedman and Cochrane Q tests were used for intra-group time-wise comparisons. Analysis results were presented as the median (q1-q3) and frequency (percentage). P<0.05 was considered statistically significant.

Table 1: Clinical assesment

Crown retention 0= yes 1= no

Individual modified gingival index 0= healthy 1= mild gingival bleeding with a papillus 2= severe inflammation

Plaque index 0= no plaque

  1. = presence of plaque as a film in the gingival margin
  2. = presence of moderate plaque
  3. = plaque covering a large number of surfaces

Color change 0 = no coloring

  1. = minor coloration
  2. = noticeable coloration

Buccal strip crown surface 0 = no loss 1 = less than 50% loss 2 = more than 50% loss 4 = loss of the entire surface

Surface abrasion of the antagonist teeth 0= no abrasion

  1. abrasion started on the incisal surface of the casps
  2. abrasion more than on the casps

Position of the crowns regarding gingival margin 0= subgingival

1= supragingival

Occlusion 0= contact (marked or superficial) 1= no contact

Condition of the antagonistic tooth 0= natural tooth

  1. restored tooth
  2. stainless steel crown
  3. aesthetic crowns

Location on the arch curve 0= normal alignment

  1. with rotation
  2. wrong position

Proximal contacts 0= good (floss passing)

1= weak, no contact

Table 2. Postoperative Radiographic Evaluation Criteria and Scores Radiographic evaluation of crown margins 0=good adaptation, continuity in crown contractions

  1. small radiolucent area under the restoration
  2. huge openings
  3. loss of restoration

Radiographic evaluation 0= healthy, no pathology

  1. presence of a pathology that does not require immediate treatment
  2. presence of pathology requiring immediate treatment

Radiographic evaluation of pulpal treatment 0=appropriate root treatment

  1. short or overflowed root treatment
  2. failed pulpal treatment
  3. tooth with no pulpal treatment

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Kayseri̇, Turkey, 38039
        • Erciyes 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients without systemic disease The American Society of Anesthesiologists (ASA)1-2,
  2. Patients under 10 years old to perform endodontic treatment for adequate root support
  3. Clinical and radiographically confirmed dental caries scored international caries detection and assessment system(icdas) criteria 4-5.
  4. Patient/parent approve

Exclusion Criteria:

  1. Patients with systemic and mental diseases
  2. Acute abscess or mobility
  3. Internal or external resorption
  4. Inadequate oral hygiene after oral health motivation that contraindicate root canal treatment
  5. Need for endocarditis prophylaxis
  6. Temporomandibular joint(TMJ) disorders, bruxism
  7. Absence of antagonistic teeth

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
Zirconia crown anterior (NuSmile, Houston, Texas, USA).
Other: Dental Crown
Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
Other Names:
  • Zirconia Crown (NuSmile, Houston, Texas, USA)
  • Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA)
  • Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Active Comparator: Group 2
Zirconia crown posterior (NuSmile, Houston, Texas, USA).
Other: Dental Crown
Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
Other Names:
  • Zirconia Crown (NuSmile, Houston, Texas, USA)
  • Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA)
  • Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Active Comparator: Group 3
Stainless steel crown (3M-ESPE, St. Paul, Minnesota, USA)
Other: Dental Crown
Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
Other Names:
  • Zirconia Crown (NuSmile, Houston, Texas, USA)
  • Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA)
  • Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Active Comparator: Group 4
Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)
Other: Dental Crown
Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
Other Names:
  • Zirconia Crown (NuSmile, Houston, Texas, USA)
  • Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA)
  • Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual examination
Time Frame: 6 months follow up period
The incidence of crown retention, gingival index, marginal crown localisation
6 months follow up period
Radiographic evaluation
Time Frame: 6 months follow up period
Periapical film: the rate of radiolucency. According to the index, each tooth was categorized as having a normal periapical structure (score 1), small changes in bone structure (score 2), changes in bone structure with some mineral loss (score 3), periodontitis with well-defined radiolucent areas (score 4), or severe apical periodontitis with exacerbating features (score 5)
6 months follow up period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionaire
Time Frame: 6 months follow up period
A Visual Analogue Scale (VAS): no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
6 months follow up period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSA-2017-6723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data (IPD) that underlie results

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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