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 (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01237782
First received: November 9, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Dental Plaque
Denture Stomatitis
Oral Candidiasis
Oral Hygiene
Drug: Denture soaking solution
Drug: Saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other Names:
  • Chemical methods for cleaning dentures
  • Chemical dentures cleaners
  • Crude drugs
  • Propolis denture cleaner
  • Propolis solution
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237782

Locations
Brazil
Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
Raphael Freitas de Souza
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Raphael Freitas de Souza, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01237782     History of Changes
Other Study ID Numbers: FORP-PT-002, 2009.1.1081.58.6, 2009/53788-9
Study First Received: November 9, 2010
Last Updated: July 24, 2014
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Candida
Complete Denture
Dental Plaque Index
Denture Bases
Denture Cleansers
Edentulous Mouth
Mutans Streptococci
Oral Health
Propolis
Streptococcus mutans

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Dental Plaque
Stomatitis
Stomatitis, Denture
Dental Deposits
Mouth Diseases
Mycoses
Stomatognathic Diseases
Tooth Diseases
Pharmaceutical Solutions
Propolis
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014