Evaluation of Sodium Hypochlorite as a Denture Cleanser
This study has been completed.
Sponsor:
University of Campinas, Brazil
Information provided by (Responsible Party):
Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01616355
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: June 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 7, 2012 | ||||||||
| Last Updated Date | June 8, 2012 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01616355 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Patients' satisfaction with the denture cleaning protocol [ Time Frame: 30, 60 and 90 days ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Sodium Hypochlorite as a Denture Cleanser | ||||||||
| Official Title ICMJE | Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm | ||||||||
| Brief Summary | The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing. |
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| Detailed Description | Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Problems With Dentures | ||||||||
| Intervention ICMJE | Other: Sodium hypochlorite immersion
Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 15 | ||||||||
| Completion Date | November 2011 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01616355 | ||||||||
| Other Study ID Numbers ICMJE | 068/2008 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil | ||||||||
| Study Sponsor ICMJE | University of Campinas, Brazil | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Campinas, Brazil | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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