Trial of a New NuSmile ZR Esthetic Primary Molar Crown
- Conditions
- Dental Caries
- Interventions
- Device: ZR CrownDevice: Stainless Steel Crown
- Registration Number
- NCT01919515
- Lead Sponsor
- NuSmile, Ltd.
- Brief Summary
The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.
- Detailed Description
The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Be between 3 and 7 years of age
- Have a minimum of two primary molar teeth, requiring crowns
- Have a parent or guardian capable of giving written informed consent
- Have study teeth in occlusion and in contact with adjacent teeth
- Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.
- Tooth is considered to be within 36 months of exfoliation
- They have a severe / serious childhood illness that requires frequent hospitalization
- They have poor general health
- They have juvenile periodontitis
- Patient is unable to return for evaluations / study recalls
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ZR Crown & Stainless Steel Crown Stainless Steel Crown Each subject will have a maximum of one ZR Crown and one Stainless Steel Crown cemented on primary molars that are treatment planned for a crown. ZR Crown & Stainless Steel Crown ZR Crown Each subject will have a maximum of one ZR Crown and one Stainless Steel Crown cemented on primary molars that are treatment planned for a crown.
- Primary Outcome Measures
Name Time Method Assessments of the SSC and ZR Crown At Baseline Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.
Assessments of the SSC and ZR Crown at 6 months 6 month visit Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 12 months 12 month visit Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 18 months 18 month visit Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 24 months 24 month visit Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of SSC and ZR Crown at 36 months 36 month visit Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of SSC and ZR Crowns at 48 months 48 month visit Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The University of Texas Health Science Center-Dental School
🇺🇸San Antonio, Texas, United States
The University of Texas Health Science Center-Ricardo Salinas Dental Clinic
🇺🇸San Antonio, Texas, United States