Problems With DenturesNCT01616355
Evaluation of Sodium Hypochlorite as a Denture Cleanser
A study testing Sodium hypochlorite immersion in people with Problems With Dentures, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Problems With Dentures
- What is being tested?
- Sodium hypochlorite immersion
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- complete denture wearers; adequate general health conditions
- ability to comply with the experimental protocol
- time of denture use: at least one year prior the study
- denture base material: heat-polymerized acrylic resin.
Who cannot join
- the use of antifungal agents or antiseptic mouthwashes during the pre-experimental and experimental period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of Piracicaba, UNICAMP
Piracicaba, São Paulo, 13414-903
About this study
Official title: Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm
The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing.
Read the detailed description
Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed.
- Conditions
- Problems With Dentures
- Being tested
- Sodium hypochlorite immersion
- Keywords
- denture, complete;, sodium hypochlorite;, disinfection;, surface roughness;, color stability.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochlorite immersionOther
Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Microorganisms reduction
Quantitative analysis of total microorganisms and Candida spp. Samples for culture were collected from dentures and saliva.
Measured: Baseline, 30, 60 and 90 days
Changes in base acrylic resin
Color stability and surface roughness evaluation
Measured: Baseline, 30, 60 and 90 days
Secondary outcomes (1)
Patients' satisfaction with the denture cleaning protocol
Measured: 30, 60 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problems With DenturesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil
- Investigators
- Altair A Del Bel Cury, PhD, Study chair, School of Dentistry of Piracicaba, State University of CampinasSheila RS Porta, PhD Student, Principal investigator, School of Dentistry of Piracicaba, State University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616355
- Sponsor's protocol ID
- 068/2008
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm
- ClinicalTrials.gov ID
- NCT01616355
- Acronym / sponsor ID
- 068/2008
- Conditions
- Problems With Dentures
- Keywords
- denture, complete;, sodium hypochlorite;, disinfection;, surface roughness;, color stability.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Jun 2012 (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 present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing.
Detailed description
Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- complete denture wearers; adequate general health conditions
- ability to comply with the experimental protocol
- time of denture use: at least one year prior the study
- denture base material: heat-polymerized acrylic resin.
Key exclusion criteria (1 listed)
- the use of antifungal agents or antiseptic mouthwashes during the pre-experimental and experimental period.
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 |
|---|---|---|
| Sodium hypochlorite immersionDentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes. | Other | – |
Primary outcome
Microorganisms reduction
Time frame: Baseline, 30, 60 and 90 days
Quantitative analysis of total microorganisms and Candida spp. Samples for culture were collected from dentures and saliva.
Changes in base acrylic resin
Time frame: Baseline, 30, 60 and 90 days
Color stability and surface roughness evaluation
1 secondary outcome
Patients' satisfaction with the denture cleaning protocol
Time frame: 30, 60 and 90 days
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 11 Jun 2012.
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.
Altair A Del Bel Cury, PhD study chair
School of Dentistry of Piracicaba, State University of Campinas
Sheila RS Porta, PhD Student principal investigator
School of Dentistry of Piracicaba, State University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hypochlorite immersion in people with Problems With Dentures, run by University of Campinas, Brazil 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 1 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 11 Jun 2012. 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. 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?
Microorganisms reduction (time frame: Baseline, 30, 60 and 90 days). The study lists 2 primary outcomes in all. 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 11 Jun 2012.