Dental PlaqueNCT01237795
Experimental Denture Pastes
A study testing Dentifrice in people with Dental Plaque and Denture Stomatitis, run by Raphael Freitas de Souza at 1 site in Brazil.
Trial summary
This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0%… 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?
- Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Dec 2009
- 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
- Completely edentulous
- Good general health
- Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures)
- Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years
- 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)
- Absence of deposits of biofilm at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Experimental Dentifrices for Cleaning Dentures
This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.
- Conditions
- Dental Plaque, Denture Stomatitis, Oral Candidiasis, Oral Hygiene
- Being tested
- Dentifrice
- Keywords
- Chloramine T, Complete Denture, Dental Plaque Index, Dentifrice, Denture Bases, Denture Cleansers, Edentulous Mouth, Fluorosurfactant, Oral Health, Toothpaste
- Medical subject headings
- Dental Plaque, Stomatitis, Denture, Candidiasis, Oral, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentifriceOther
Also called Denture-specific paste, Toothpaste
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
| Study group | Role | What they receive |
|---|---|---|
| 0.01% fluorosurfactant | Experimental | An experimental formula for denture hygiene containing 0.01% fluorosurfactant. Receives: Other: Dentifrice |
| 1.0% chloramine T | Experimental | An experimental formula for denture hygiene containing 1.0% chloramine T. Receives: Other: Dentifrice |
| 0.2% chloramine T | Experimental | An experimental formula for denture hygiene containing 0.2% chloramine T. Receives: Other: Dentifrice |
| Proprietary dentifrice. | Active comparator | A proprietary denture-specific dentifrice. Receives: Other: Dentifrice |
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: 7 days
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 startFeb 2008
- Primary completionJun 2008
- Study completionDec 2009
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphael Freitas de Souza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raphael Freitas de Souza, University of Sao Paulo
- Investigators
- Helena FO Paranhos, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237795
- Sponsor's protocol ID
- FORP-PT-003
- Other IDs
- 2008.1.33.58.7
- 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
- A Randomized Trial of Experimental Dentifrices for Cleaning Dentures
- ClinicalTrials.gov ID
- NCT01237795
- Acronym / sponsor ID
- FORP-PT-003
- Conditions
- Dental Plaque, Denture Stomatitis, Oral Candidiasis, Oral Hygiene
- Keywords
- Chloramine T, Complete Denture, Dental Plaque Index, Dentifrice, Denture Bases, Denture Cleansers, Edentulous Mouth, Fluorosurfactant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Raphael Freitas de SouzaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2009 (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.
This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.01% fluorosurfactant | Experimental | Other: DentifriceAn experimental formula for denture hygiene containing 0.01% fluorosurfactant. |
| 1.0% chloramine T | Experimental | Other: DentifriceAn experimental formula for denture hygiene containing 1.0% chloramine T. |
| 0.2% chloramine T | Experimental | Other: DentifriceAn experimental formula for denture hygiene containing 0.2% chloramine T. |
| Proprietary dentifrice. | Active comparator | Other: DentifriceA proprietary denture-specific dentifrice. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous
- Good general health
- Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures)
- Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years
- 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)
- Absence of deposits of biofilm at baseline
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 |
|---|---|---|
| DentifriceAlso: Denture-specific paste, ToothpasteDentifrices (4 formulations) used as auxiliary agents for brushing complete dentures. | Other | 0.01% fluorosurfactant, 0.2% chloramine T, 1.0% chloramine T, Proprietary dentifrice. |
Primary outcome
Denture plaque coverage area (%)
Time frame: 7 days
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
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.
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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.
Helena FO Paranhos, 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 Dentifrice 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 5 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. 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: 7 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 28 Jul 2014.