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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02572570 |
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Date of registration:
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21/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
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Scientific title:
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Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02572570 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Rick Walter, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be 18 years of age and older
- Have a pair of similar cavities or failed dental fillings in vital permanent posterior
teeth requiring treatment
- Be capable of giving written informed consent.
Exclusion Criteria:
- Have a self-reported history of any adverse reaction to materials of the types to be
evaluated
- Have a medical or dental history that could possibly complicate the provision of the
proposed treatment and/or influence the behavior and performance of the treatment in
clinical service.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dental Caries
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Fracture of Dental Restorative Materials With Loss of Material
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Dental Restoration Failure of Marginal Integrity
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Fractured Dental Restorative Materials Without Loss of Materials
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Secondary Dental Caries Associated With Failed or Defective Dental Restorations
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Poor Aesthetics of Existing Restoration
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Unrepairable Overhanging of Dental Restorative Materials
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Intervention(s)
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Device: Filtek Bulk Fill Posterior
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Device: Filtek Supreme Ultra
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Primary Outcome(s)
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Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 2
[Time Frame: Baseline, Year 2]
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Secondary Outcome(s)
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Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at 6 months
[Time Frame: Baseline, 6 Months]
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Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at 6 Months
[Time Frame: Baseline, 6 Months]
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Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 3
[Time Frame: Baseline, Year 3]
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Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 1
[Time Frame: Baseline, Year 1]
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Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 2
[Time Frame: Baseline, Year 2]
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Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 3
[Time Frame: Baseline, Year 3]
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Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 1
[Time Frame: Baseline, Year 1]
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Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 5
[Time Frame: Baseline, Year 5]
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Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 5
[Time Frame: Baseline, Year 5]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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