Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves

Effectiveness of Zirconia-based Crowns With Retention Grooves (Sprig EZ) Versus Without Retention Grooves (NuSmile ZR) for Restoration of Primary Anterior Teeth: A Parallel-arm Randomized Controlled Trial

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Tooth Decay
• Intervention / Treatment: Procedure: Zirconia-based primary anterior crowns with retention grooves; Procedure: Zirconia-based primary anterior crowns without retention grooves

Detailed Description

There are many treatment options available for restoring primary anterior teeth. A clinician's decision to opt for any specific treatment option is based on multiple factors such as the clinician's liking of a specific material or method, esthetic demands by parents, the child's behavior, and moisture and hemorrhage control. Out of many treatment options, preformed zirconia crowns for primary teeth have been available for over a decade. There is insufficient research that compares the success of anterior pediatric zirconia crowns with and without retentive grooves.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy 2 to 6-year-old children.
• Those having opposed anterior teeth.
• No history of systemic illness or dental developmental anomalies
• Minimal of two surfaces of caries in the upper anterior teeth.
• Patient with Early Childhood Caries.
• Patients treated under General Anesthesia.
• English, Spanish, and Arabic speaking patients

Exclusion Criteria:

• Teeth nearing exfoliation.
• The presence of a single surface caries, not involving the proximal surfaces.
• Teeth that have been subjected to trauma.
• Bruxism.
• Special health needs.
• Presence of teeth wear on the opposing teeth, or absence of opposing teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zirconia-based primary anterior crowns with retention grooves; Participants will receive zirconia-based primary anterior crowns with retention grooves	Procedure: Zirconia-based primary anterior crowns with retention grooves; Zirconia-based primary anterior crowns with retention grooves
Experimental: Zirconia-based primary anterior crowns without retention grooves; Participants will receive zirconia-based primary anterior crowns without retention grooves	Procedure: Zirconia-based primary anterior crowns without retention grooves; Zirconia-based primary anterior crowns without retention grooves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes	The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately: Contour of crown, Gingival health, Staining of crown, Surface roughness of crown, Opposing tooth, Color match of crown, Marginal fit, Marginal discoloration, Recurrent caries.	3, 6, 12, 24 and 36 months
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes	The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes/no) of the findings for the following parameter separately: Widening of periodontal ligament space, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.	3, 6, 12, 24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental satisfaction	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.	3, 12, 24 and 36 months
Child satisfaction	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.	3, 12, 24 and 36 months
Oral health impact during early childhood	Evaluating Oral health impact during early childhood utilizing the Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire. This is rated on a Likert 5-point scale. (0 = never, 1 = hardly ever, 2 = occasionally, 3 = often, 4 = very often)	3, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jayakumar Jayaraman, MDS, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: HM20028419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No