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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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14 December 2015 |
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Main ID: |
NCT02339194 |
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Date of registration:
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12/01/2015 |
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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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Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges
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Scientific title:
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Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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72 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02339194 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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Phase:
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Phase 3
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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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Samara M Sales, DDS |
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Address:
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Telephone:
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8596523217 |
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Email:
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samarah_sales@hotmail.com |
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Affiliation:
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Name:
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Samara M Sales, DDS |
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Address:
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Telephone:
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8596523217 |
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Email:
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samarah_sales@hotmail.com |
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Affiliation:
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Name:
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Romulo R Regis, 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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romuloregis@hotmail.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- complete edentulism for at least one year;
- desire to receive a pair of new conventional complete dentures
- mental receptiveness;
- good understanding of spoken Portuguese
Exclusion Criteria:
- disorders of the masticatory system;
- pathological changes of residual ridges;
- debilitating systemic diseases.
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Edentulous Jaw
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Edentulous Mouth
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Intervention(s)
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Procedure: Denture fabrication technique
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Primary Outcome(s)
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Oral health related quality of life
[Time Frame: 6 months]
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Secondary Outcome(s)
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Masticatory performance (assessed by means of a colorimetric method based on an artificial test food)
[Time Frame: 6 months]
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Denture quality (assessed by means of a clinical examination according to a specific form)
[Time Frame: 3 months]
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Satisfaction with dentures (assessed by means of two specific questionaries)
[Time Frame: 6 months]
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Secondary ID(s)
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136958818
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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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