Can Zirconia Crown be the First Choice for Primary Teeth?

NCT04574180 | Completed DMC

• 1 other identifier: TSA-2017-6723
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries in Children

Keywords

zirconia; crown; endodontic; pediatric

Outcome Measures

Primary Outcomes (2)

• Visual examination

  The incidence of crown retention, gingival index, marginal crown localisation

  6 months follow up period

• Radiographic evaluation

  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 Outcomes (1)

• Questionaire

  6 months follow up period

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Zirconia crown anterior (NuSmile, Houston, Texas, USA).

Other: Dental Crown

Group 2

ACTIVE COMPARATOR

Zirconia crown posterior (NuSmile, Houston, Texas, USA).

Other: Dental Crown

Group 3

ACTIVE COMPARATOR

Stainless steel crown (3M-ESPE, St. Paul, Minnesota, USA)

Other: Dental Crown

Group 4

ACTIVE COMPARATOR

Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)

Other: Dental Crown

Interventions

Dental Crown OTHER

Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.

Also known as: Zirconia Crown (NuSmile, Houston, Texas, USA), Stainless Steel Crown (3M-ESPE, St. Paul, Minnesota, USA), Strip Crown (3M-ESPE, St. Paul, Minnesota, USA)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (5)

• Walia T, Brigi C, KhirAllah ARMM. Comparative evaluation of surface roughness of posterior primary zirconia crowns. Eur Arch Paediatr Dent. 2019 Feb;20(1):33-40. doi: 10.1007/s40368-018-0382-4. Epub 2018 Oct 20.

  PMID: 30343392 BACKGROUND

• Seminario AL, Garcia M, Spiekerman C, Rajanbabu P, Donly KJ, Harbert P. Survival of Zirconia Crowns in Primary Maxillary Incisors at 12-, 24- and 36-Month Follow-Up. Pediatr Dent. 2019 Sep 15;41(5):385-390.

  PMID: 31648670 BACKGROUND

• El Makawi Y, Khattab N. In Vitro Comparative Analysis of Fracture Resistance of Lithium Disilicate Endocrown and Prefabricated Zirconium Crown in Pulpotomized Primary Molars. Open Access Maced J Med Sci. 2019 Dec 13;7(23):4094-4100. doi: 10.3889/oamjms.2019.864. eCollection 2019 Dec 15.

  PMID: 32165959 BACKGROUND

• Sonbol HN, Al-Bitar ZB, Shraideh AZ, Al-Omiri MK. Parental-caregiver perception of child oral-health related quality of life following zirconia crown placement and non-restoration of carious primary anterior teeth. Eur J Paediatr Dent. 2018 Mar;19(1):21-28. doi: 10.23804/ejpd.2018.19.01.04.

  PMID: 29569449 BACKGROUND

• Lee JH. Guided tooth preparation for a pediatric zirconia crown. J Am Dent Assoc. 2018 Mar;149(3):202-208.e2. doi: 10.1016/j.adaj.2017.08.048. Epub 2018 Feb 1.

  PMID: 29395008 BACKGROUND

MeSH Terms

Interventions

Crowns

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocciate Prof

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 5, 2020
• Study Start: January 1, 2017
• Primary Completion: March 9, 2018
• Study Completion: September 9, 2019
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)