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

NCT06354647 | Completed

• 1 other identifier: HM20028419
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Tooth Decay

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Parental satisfaction

  3, 12, 24 and 36 months

• Child satisfaction

  3, 12, 24 and 36 months

• Oral health impact during early childhood

  3, 12, 24 and 36 months

Study Arms (2)

Zirconia-based primary anterior crowns with retention grooves

EXPERIMENTAL

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 without retention grooves

EXPERIMENTAL

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

Procedure: Zirconia-based primary anterior crowns without retention grooves

Interventions

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

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

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jayakumar Jayaraman, MDS, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: June 7, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)