Efficacy of a Propolis-based Denture Cleanser

NCT01237782 | Completed

• 3 other identifiers: FORP-PT-0022009.1.1081.58.62009/53788-9
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Denture Stomatitis; Oral Candidiasis; Oral Hygiene

Keywords

Candida; Complete Denture; Dental Plaque Index; Denture Bases; Denture Cleansers; Edentulous Mouth; Mutans Streptococci; Oral Health; Propolis; Streptococcus mutans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• mutans streptococci counts (CFU)

  At the same day of the intervention, up to 1 hour following denture soaking

• Candida spp. counts (CFU)

  At the same day of the intervention, up to 1 hour following denture soaking

Study Arms (2)

Propolis solution

EXPERIMENTAL

A proprietary denture cleanser with propolis as the active agent.

Drug: Denture soaking solution

Saline solultion

PLACEBO COMPARATOR

Physiologic saline solution.

Drug: Saline solution

Interventions

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).

Also known as: Chemical methods for cleaning dentures, Chemical dentures cleaners, Crude drugs, Propolis denture cleaner, Propolis solution

Propolis solution

Saline solution DRUG

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

Saline solultion

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
• Pathologic changes in the oral cavity

Sponsors & Collaborators

• Raphael Freitas de Souza: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Links

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

MeSH Terms

Conditions

Dental Plaque; Stomatitis, Denture; Candidiasis, Oral; Torulopsis; Mouth, Edentulous

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Stomatitis; Mouth Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Raphael F de Souza, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

BR (1)