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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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8 January 2024 |
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Main ID: |
NCT03343184 |
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Date of registration:
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10/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Evaluation of Bulk Fill Composite Restorations Associated to Universal Adhesive System
FBFSBU |
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Scientific title:
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Clinical Evaluation of Restorations With Filtek Bulk Fill, Associated With Single Bond Universal, With Different Adhesive Strategies |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03343184 |
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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: Parallel 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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Brazil
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Contacts
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Name:
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MARCOS O BARCELEIRO, DDS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidade Federal Fluminense |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients must have at only 20 teeth in function, must have at only 4 carious
occlusal or proximo-occlusal lesions, or old restorations that need to be changed, in
different teeth. Those lesions must be more than 2 mm deep, should have exposed
dentin, and must have at only 50% of margins in enamel. Teeth should not present
periodontal mobility.
Exclusion Criteria:
- Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory
drugs in the last 30 days.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dental Restoration Failure of Marginal Integrity
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Intervention(s)
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Procedure: SEE Strategy and Incremental Restoration
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Procedure: SET Strategy and Incremental Restoration
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Procedure: SEE Strategy and Bulk Fill Restoration
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Procedure: SET Strategy and Bulk Fill Restoration
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Primary Outcome(s)
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Restoration Loss
[Time Frame: Five years]
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Secondary Outcome(s)
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Secondary Caries
[Time Frame: Five years]
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Marginal Pigmentation
[Time Frame: Five years]
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Post-Operative Hypersensitivity
[Time Frame: Five years]
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Secondary ID(s)
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UFFNFBULKANDUNIVERSAL2017
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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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