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
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
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 |
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