Dental PlaqueNCT01237782
Efficacy of a Propolis-based Denture Cleanser
A study testing Denture soaking solution and Saline solution in people with Dental Plaque and Denture Stomatitis, run by Raphael Freitas de Souza at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Denture Stomatitis, Oral Candidiasis
- What is being tested?
- Denture soaking solution and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
- Pathologic changes in the oral cavity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial
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
- Being tested
- Denture soaking solution, Saline solution
- Keywords
- Candida, Complete Denture, Dental Plaque Index, Denture Bases, Denture Cleansers, Edentulous Mouth, Mutans Streptococci, Oral Health, Propolis, Streptococcus mutans
- Medical subject headings
- Dental Plaque, Stomatitis, Denture, Candidiasis, Oral, Torulopsis, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture soaking solutionDrug
Also called Chemical methods for cleaning dentures, Chemical dentures cleaners, Crude drugs, Propolis denture cleaner
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 solutionDrug
Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Propolis solution | Experimental | A proprietary denture cleanser with propolis as the active agent. Receives: Drug: Denture soaking solution |
| Saline solultion | Placebo comparator | Physiologic saline solution. Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture plaque coverage area (%)
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
Measured: At the same day of the intervention, up to 1 hour following denture soaking
Secondary outcomes (2)
mutans streptococci counts (CFU)
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
Measured: 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.
Measured: At the same day of the intervention, up to 1 hour following denture soaking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphael Freitas de Souza
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Raphael Freitas de Souza, University of Sao Paulo
- Investigators
- Raphael F de Souza, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237782
- Sponsor's protocol ID
- FORP-PT-002
- Other IDs
- 2009.1.1081.58.6, 2009/53788-9, 2009
- Status last verified
- Jul 2014
- First submitted
- 9 Nov 2010
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT01237782
- Acronym / sponsor ID
- FORP-PT-002
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Raphael Freitas de SouzaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis solution | Experimental | Drug: Denture soaking solutionA proprietary denture cleanser with propolis as the active agent. |
| Saline solultion | Placebo comparator | Drug: Saline solutionPhysiologic saline solution. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
- Pathologic changes in the oral cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denture soaking solutionAlso: Chemical methods for cleaning dentures, Chemical dentures cleaners, Crude drugs, Propolis denture cleanerImmersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan). | Drug | Propolis solution |
| Saline solutionImmersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes. | Drug | Saline solultion |
Primary outcome
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.
2 secondary outcomes
mutans streptococci counts (CFU)
Time frame: At the same day of the intervention, up to 1 hour following denture soaking
Candida spp. counts (CFU)
Time frame: At the same day of the intervention, up to 1 hour following denture soaking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Institutional page of the Ribeirão Preto Dental School (research site)Link provided by the sponsor.
- Principal Investigator´s CVLink provided by the sponsor.
Related trials for Dental Plaque
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
Not yet recruiting
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Gingivitis, Healthy Adult
Recruiting
A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
Dental Plaque, Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael F de Souza, DDS, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denture soaking solution and Saline solution in people with Dental Plaque and Denture Stomatitis, run by Raphael Freitas de Souza at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denture plaque coverage area (%) (time frame: At the same day of the intervention, up to 1 hour following denture soaking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.