Trials / Completed
CompletedNCT06354634
Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth
Clinical and Radiographic Success of Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel (3M ESPE) Crowns for Restoration of Primary Molar Teeth: a Split Mouth Randomized Controlled Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Virginia Commonwealth University · Academic / Other
- Sex
- All
- Age
- 3 Years – 7 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Resin polymer (NuSmile Bioflx) crown | Resin polymer (NuSmile Bioflx)crown |
| OTHER | Stainless steel crown | Stainless steel crown |
Timeline
- Start date
- 2024-06-07
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
- First posted
- 2024-04-09
- Last updated
- 2025-02-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06354634. Inclusion in this directory is not an endorsement.