Denture Hygiene ProtocolNCT01906242
Hygiene Protocol of Complete Dentures
A study testing water, sodium hypochlorite and sodium bicarbonate in people with Denture Hygiene Protocol, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Hygiene Protocol
- What is being tested?
- water, sodium hypochlorite and sodium bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Dec 2013
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Complete denture wearer
- healthy
- ability to comply with the experimental protocol
Who cannot join
- Candidiasis (thrush)
- use of antifungals, antibiotics or mouthwashes in the prior 3 months
- limited motor activity
- unhealthy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hygiene Protocols for Cleaning Complete Dentures
Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.
- Conditions
- Denture Hygiene Protocol
- Being tested
- water, sodium hypochlorite, sodium bicarbonate, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterOther
Also called placebo
sodium hypochloriteOther
sodium bicarbonateOther
chlorhexidineOther
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Patients' dentures are treated with water (placebo) once a week for 10 min. Receives: Other: water |
| sodium hypochlorite | Active comparator | Patients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min Receives: Other: sodium hypochlorite |
| 0.5% chlorhexidine | Active comparator | Patients' dentures are treated with 0.5% chlorhexidine once a week for 10 min. Receives: Other: chlorhexidine |
| 0.12% sodium bicarbonate | Active comparator | Patients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min. Receives: Other: sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of biofilm formed on the denture
Biofilm will be measured on the denture using photographs and microbial counts (baseline and after 14 days of use of one of the four hygiene protocols) after using one of the tested denture hygiene protocols. The four tested protocols (NaOCl, chlorhexidine, sodium bicarbonate, water) will be compared to see which one leads to a better hygiene of the denture.
Measured: 14 days
Secondary outcomes (1)
Odor
Patients will be asked about the odor of the solution used to soak dentures through a questionnaire
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture Hygiene ProtocolStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Tatiana Pereira-Cenci, PhD, Principal investigator, Federal University of PelotasMaximiliano S Cenci, PhD, Study chair, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906242
- Sponsor's protocol ID
- PPGO016
- Status last verified
- Nov 2018
- First submitted
- 3 May 2013
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hygiene Protocols for Cleaning Complete Dentures
- ClinicalTrials.gov ID
- NCT01906242
- Acronym / sponsor ID
- PPGO016
- Conditions
- Denture Hygiene Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jul 2013 (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.
Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: waterPatients' dentures are treated with water (placebo) once a week for 10 min. |
| sodium hypochlorite | Active comparator | Other: sodium hypochloritePatients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min |
| 0.5% chlorhexidine | Active comparator | Other: chlorhexidinePatients' dentures are treated with 0.5% chlorhexidine once a week for 10 min. |
| 0.12% sodium bicarbonate | Active comparator | Other: sodium bicarbonatePatients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complete denture wearer
- healthy
- ability to comply with the experimental protocol
Key exclusion criteria (4 listed)
- Candidiasis (thrush)
- use of antifungals, antibiotics or mouthwashes in the prior 3 months
- limited motor activity
- unhealthy
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 |
|---|---|---|
| waterAlso: placebo | Other | Water |
| sodium hypochlorite | Other | sodium hypochlorite |
| sodium bicarbonate | Other | 0.12% sodium bicarbonate |
| chlorhexidine | Other | 0.5% chlorhexidine |
Primary outcome
Amount of biofilm formed on the denture
Time frame: 14 days
Biofilm will be measured on the denture using photographs and microbial counts (baseline and after 14 days of use of one of the four hygiene protocols) after using one of the tested denture hygiene protocols. The four tested protocols (NaOCl, chlorhexidine, sodium bicarbonate, water) will be compared to see which one leads to a better hygiene of the denture.
1 secondary outcome
Odor
Time frame: 14 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 15 Nov 2018.
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.
Tatiana Pereira-Cenci, PhD principal investigator
Federal University of Pelotas
Maximiliano S Cenci, PhD study chair
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water, sodium hypochlorite and sodium bicarbonate in people with Denture Hygiene Protocol, run by Federal University of Pelotas 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 3 inclusion and 4 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 15 Nov 2018. 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?
Amount of biofilm formed on the denture (time frame: 14 days). 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 15 Nov 2018.