Clinical trial NCT06354647: Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Tooth Decay
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes
timeFrame: 3, 6, 12, 24 and 36 months
measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes
timeFrame: 3, 6, 12, 24 and 36 months
Secondary outcomes:
measure: Parental satisfaction
timeFrame: 3, 12, 24 and 36 months
measure: Child satisfaction
timeFrame: 3, 12, 24 and 36 months
measure: Oral health impact during early childhood
timeFrame: 3, 12, 24 and 36 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jayakumar Jayaraman, MDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: