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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354647
• Other study ID #: HM20028419
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD
• Phone: (804) 828-9095
• Email: jayaramanj[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Procedure:
• Zirconia-based primary anterior crowns with retention grooves
Zirconia-based primary anterior crowns with retention grooves
• Zirconia-based primary anterior crowns without retention grooves
Zirconia-based primary anterior crowns without retention grooves

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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