Efficacy of a Propolis-based Denture Cleanser

This study has been completed.

Sponsor:

Collaborator:

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01237782

First received: November 9, 2010

Last updated: August 3, 2011

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2010

Last Updated Date

August 3, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Denture plaque coverage area (%) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ] [ Designated as safety issue: No ]

Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Original Primary Outcome Measures ^ICMJE

Denture plaque coverage area (%) [ Time Frame: Immediately after the interventions ] [ Designated as safety issue: No ]

Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Change History

Complete list of historical versions of study NCT01237782 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

mutans streptococci counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.

Original Secondary Outcome Measures ^ICMJE

mutans streptococci counts (CFU) [ Time Frame: Immediately after the interventions ] [ Designated as safety issue: No ]
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
Candida spp. counts (CFU) [ Time Frame: Immediately after the interventions ] [ Designated as safety issue: No ]
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of a Propolis-based Denture Cleanser

Official Title ^ICMJE

Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial

Brief Summary

The purpose of this study is to assess if a propolis solution is able to remove plaque and kill microbes from complete dentures. The investigators will compare the results of the propolis-based denture cleanser with those obtained with an inactive solution.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Dental Plaque
Denture Stomatitis
Oral Candidiasis
Oral Hygiene

Intervention ^ICMJE

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).
Other Names:
- Chemical methods for cleaning dentures
- Chemical dentures cleaners
- Crude drugs
- Propolis denture cleaner
- Propolis solution
Drug: Saline solution
Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.

Study Arm (s)

Experimental: Propolis solution
A proprietary denture cleanser with propolis as the active agent.

Intervention: Drug: Denture soaking solution
Placebo Comparator: Saline solultion
Physiologic saline solution.

Intervention: Drug: Saline solution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Good general health
Patients requesting new complete dentures
Regular wearing of the same maxillary and mandibular complete dentures for at least one year
Both denture bases and artificial teeth should be composed by acrylic resin

Exclusion Criteria:

Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
Pathologic changes in the oral cavity

Gender

Both

Ages

45 Years and older

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

NCT01237782

Other Study ID Numbers ^ICMJE

FORP-PT-002, 2009.1.1081.58.6, 2009/53788-9

Has Data Monitoring Committee

Responsible Party

Raphael Freitas de Souza, University of Sao Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

Principal Investigator:

Raphael F de Souza, DDS, PhD

University of Sao Paulo

Information Provided By

University of Sao Paulo

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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