Dental Caries, Tooth Decay
Conditions
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.
Interventions
PROCEDUREZirconia-based primary anterior crowns with retention grooves
Zirconia-based primary anterior crowns with retention grooves
PROCEDUREZirconia-based primary anterior crowns without retention grooves
Zirconia-based primary anterior crowns without retention grooves
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes | 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. |
| Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes | 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
| Measure | Time frame | Description |
|---|---|---|
| Parental satisfaction | 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. |
| Child satisfaction | 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. |
| Oral health impact during early childhood | 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) |
Countries
United States
Outcome results
None listed