Efficacy of a Propolis-based Denture Cleanser

Not Applicable

Completed

• Conditions: Denture Stomatitis; Dental Plaque; Oral Candidiasis; Oral Hygiene
• Interventions: Drug: Saline solution; Drug: Denture soaking solution

• Registration Number: NCT01237782
• Lead Sponsor: Raphael Freitas de Souza

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 available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline solultion	Saline solution	Physiologic saline solution.
Propolis solution	Denture soaking solution	A proprietary denture cleanser with propolis as the active agent.

Primary Outcome Measures

Name	Time	Method
Denture plaque coverage area (%)	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.

Secondary Outcome Measures

Name	Time	Method
mutans streptococci counts (CFU)	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)	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.

Trial Locations

Locations (1)

Ribeirão Preto Dental School; 🇧🇷 Ribeirão Preto, São Paulo, Brazil