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

Not Applicable

Completed

• Conditions: Tooth Decay; Dental Caries
• Interventions: Procedure: Zirconia-based primary anterior crowns with retention grooves; Procedure: Zirconia-based primary anterior crowns without retention grooves

• Registration Number: NCT06354647
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-09
• Study Start: 2024-06-07
• Status Verified: 2025-02
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zirconia-based primary anterior crowns with retention grooves	Zirconia-based primary anterior crowns with retention grooves	Participants will receive zirconia-based primary anterior crowns with retention grooves
Zirconia-based primary anterior crowns without retention grooves	Zirconia-based primary anterior crowns without retention grooves	Participants will receive zirconia-based primary anterior crowns without retention grooves

Primary Outcome Measures

Name	Time	Method
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes	3, 6, 12, 24 and 36 months	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.
Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes	3, 6, 12, 24 and 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Parental satisfaction	3, 12, 24 and 36 months	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.
Child satisfaction	3, 12, 24 and 36 months	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.
Oral health impact during early childhood	3, 12, 24 and 36 months	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)

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States