Efficacy of a Propolis-based Denture Cleanser
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|ClinicalTrials.gov Identifier: NCT01237782|
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : July 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dental Plaque Denture Stomatitis Oral Candidiasis Oral Hygiene||Drug: Denture soaking solution Drug: Saline solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Propolis solution
A proprietary denture cleanser with propolis as the active agent.
Drug: Denture soaking solution
Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan).
Placebo Comparator: Saline solultion
Physiologic saline solution.
Drug: Saline solution
Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.
- Denture plaque coverage area (%) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ]Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
- mutans streptococci counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ]Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
- Candida spp. counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ]Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237782
|Ribeirão Preto Dental School|
|Ribeirão Preto, São Paulo, Brazil, 14040-904|
|Principal Investigator:||Raphael F de Souza, DDS, PhD||University of Sao Paulo|