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The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.
There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | Each participant will receive a BioFLX crown and a stainless steel crown. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin polymer (NuSmile Bioflx) crown | Other | Resin polymer (NuSmile Bioflx)crown |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments | 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, 18, 24 and 36 months |
| The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments | 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, furcation radiolucency, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption. | 3, 6, 12, 18, 24 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Child satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003442 | Crowns |
| ID | Term |
|---|---|
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
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Each participant will receive both interventions.
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| Stainless steel crown |
| Other |
Stainless steel crown |
|
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 |
| ECOHIS (Early Childhood Oral Health Impact Scale) survey | The questionnaire is a Likert scale of 1-5. 1 equals never. 5 equals very often. The lower the score, the better. | Pre-operative, 6, 12, 24 and 36 months |
| D004864 |
| Equipment and Supplies |