Efficacy of a Propolis-based Denture Cleanser

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237782
• Other study ID #: FORP-PT-002
• Secondary ID: 2009.1.1081.58.6
• Status: Completed
• Phase: N/A
• First received: November 9, 2010
• Last updated: July 24, 2014
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• Dental Plaque
• Denture Stomatitis
• Oral Candidiasis
• Oral Hygiene
• Stomatitis
• Stomatitis, Denture

Intervention

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).
• Saline solution
Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.

Locations

Country	Name	City	State
Brazil	Ribeirão Preto Dental School	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Raphael Freitas de Souza	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Denture plaque coverage area (%)	Relation between stained area and total surface area on the internal surface of maxillary complete dentures.	At the same day of the intervention, up to 1 hour following denture soaking	No
Secondary	mutans streptococci counts (CFU)	Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.	At the same day of the intervention, up to 1 hour following denture soaking	No
Secondary	Candida spp. counts (CFU)	Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.	At the same day of the intervention, up to 1 hour following denture soaking	No

External Links

•   Institutional page of the Ribeirão Preto Dental School (research site)
•   Principal Investigator´s CV