Efficacy of a Propolis-based Denture Cleanser

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Denture soaking solution
* Drug: Saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propolis solution<br>A proprietary denture cleanser with propolis as the active agent. | Drug: Denture soaking solution<br>* Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan).<br>* Other names: Propolis solution;|
| Placebo Comparator: Saline solultion<br>Physiologic saline solution. | Drug: Saline solution<br>* Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candida, Complete Denture, Dental Plaque Index, Denture Bases, Denture Cleansers, Edentulous Mouth, Mutans Streptococci, Oral Health, Propolis, Streptococcus mutans