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Completed

NCT Number: NCT01237782

Efficacy of a Propolis-based Denture Cleanser

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.

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Key information

Conditions

Dental Plaque Bacterial Infections and Mycoses Candidiasis Candidiasis, Oral Dental Deposits Denture Stomatitis Infections Mouth Diseases Mouth, Edentulous Mycoses Oral Candidiasis Oral Hygiene Stomatitis Stomatitis, Denture Stomatognathic Diseases Tooth Diseases Torulopsis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denture soaking solution

Drug

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

Saline Solution

Drug

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

Primary outcomes

  1. Denture plaque coverage area (%)

    Time frame: 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 outcomes

  1. mutans streptococci counts (CFU)

    Time frame: 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.

  2. Candida spp. counts (CFU)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Raphael Freitas de Souza

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2010
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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