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

NCT ID: NCT06354647

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2025-02-01

Brief Summary

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.

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.

Conditions

Dental Caries; Tooth Decay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zirconia-based primary anterior crowns with retention grooves

Participants will receive zirconia-based primary anterior crowns with retention grooves

Group Type: EXPERIMENTAL

Zirconia-based primary anterior crowns with retention grooves

Intervention Type: PROCEDURE

Zirconia-based primary anterior crowns with retention grooves

Zirconia-based primary anterior crowns without retention grooves

Participants will receive zirconia-based primary anterior crowns without retention grooves

Group Type: EXPERIMENTAL

Zirconia-based primary anterior crowns without retention grooves

Intervention Type: PROCEDURE

Zirconia-based primary anterior crowns without retention grooves

Interventions

Zirconia-based primary anterior crowns with retention grooves

Zirconia-based primary anterior crowns with retention grooves

Intervention Type: PROCEDURE

Zirconia-based primary anterior crowns without retention grooves

Zirconia-based primary anterior crowns without retention grooves

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayakumar Jayaraman, MDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20028419

Identifier Type: -

Identifier Source: org_study_id