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OpenTrials
Completed

NCT Number: NCT06354647

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

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Zirconia-based primary anterior crowns without retention grooves

Primary outcomes

  1. Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes

    Time frame: 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.

  2. Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes

    Time frame: 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 outcomes

  1. Parental satisfaction

    Time frame: 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.

  2. Child satisfaction

    Time frame: 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.

  3. Oral health impact during early childhood

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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