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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

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
      • 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

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
Intervention / Treatment
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

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

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

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)

January 1, 2017

Primary Completion (Actual)

March 9, 2018

Study Completion (Actual)

September 9, 2019

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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