Tooth CariesNCT03502538
A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes
A study testing Curaprox 5460 Ultra Soft and Oral-B Indicator Plus in people with Tooth Caries and Dental Plaque, run by University of Brasilia.
Trial summary
Objective: To compare the efficacy of Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus toothbrushes in dental plaque removal. Methods: 50 adult participants will be included in the sample. For a period of 24 hours (at two different times), they will be instructed to stop oral hygiene. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Caries, Dental Plaque
- What is being tested?
- Curaprox 5460 Ultra Soft and Oral-B Indicator Plus
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Oct 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral health
- At least, 24 health teeth
Who cannot join
- Those with any limitations that make it difficult for the dental examination or the performance of brushing, which use removable prostheses, orthodontic appliances, and/or that have malocclusions, and the presence of a gingival recess equal to or greater than 2mm
About this study
Official title: A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes Models: Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus
Objective: To compare the efficacy of Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus toothbrushes in dental plaque removal. Methods: 50 adult participants will be included in the sample. For a period of 24 hours (at two different times), they will be instructed to stop oral hygiene. During the final 4 hours, the interruption of consumption of foods and liquids will be recommended, and in smokers' case, the use of cigarettes. In two clinical visits (T0 and T1), volunteers will be asked to brush their teeth for 1 minute with Curaprox® (CS 5460 Ultra Soft) e Oral-B® (Indicator Plus) toothbrushes. Disclosure will be performed prior to and after brushing and the presence of plaque on the tooth surfaces will be evaluated. Turesky Modified Quigley Hein Plaque Index will be used for the plaque record. For statistical analysis, paired t tests will be performed to compare the effectiveness of toothbrushes and correlation test to assess whether the fact that the patient was aware of the toothbrush that will be used influenced in their performance.
Read the detailed description
For the study, 50 patients, between 18 and 55 years of age, of both sexes and healthy will be selected. For the study performance, volunteers will be instructed to stop their brushing for 23 to 25 hours before the first clinical visit. In addition, they will be also instructed to stop eating (solid foods and liquids) and to stop the use of cigarettes, if smoker, for 4 hours before evaluation. Prior to the study, a pilot study will be conducted at the University Hospital of Brasília for the researcher calibration using the Turesky Modified Quigley Hein Plaque Index, following the predetermined protocol.
A double-blind crossover study will be designed in which each volunteer will test two different models of toothbrushes. Prior to the beginning of the study, the brushes handle will be hidden with tape in a way that it will be not possible to see the toothbrush trademark. During the two visits, both brushes will be placed on the workbench and in the absence of the researcher, the participant will select one of the brushes. In the following visit, the same procedure will be performed and the participant will use the second brush. A period of washout of at least one week between the the first visit and the second visit will be done to obtain non-interference between results. No brush restriction will be imposed for the participant during this period.
- Conditions
- Tooth Caries, Dental Plaque
- Being tested
- Curaprox 5460 Ultra Soft, Oral-B Indicator Plus
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curaprox 5460 Ultra SoftDevice
The toothbrush Curaprox 5460 Ultra Soft will be the tested toothbrush model, in order to asses its efficacy in plaque removal. Therefore, the study participants should brush their teeth using this toothbrush model, following the instructions of the investigator. From the data collect related in plaque removal the results will be arrived at.
Oral-B Indicator PlusDevice
Following the same method of the Curaprox group intervention, the participants should brush their teeth using the Oral-B Indicator Plus toothbrush and based on the data collect, the results will be compared with the first group of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Curaprox 5460 Ultra Soft | Experimental | Brushing with a Curaprox Ultra Soft 5460 toothbrush for one minute timed without orientations about brushing techniques and without supervision Receives: Device: Curaprox 5460 Ultra Soft; Device: Oral-B Indicator Plus |
| Oral-B Indicator Plus | Active comparator | Brushing with a Oral-B Indicator Plus toothbrush for one minute timed without orientations about brushing techniques and without supervision Receives: Device: Curaprox 5460 Ultra Soft; Device: Oral-B Indicator Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of dental plaque removal between the toothbrushes Curaprox and Oral-B
The participants should stay for 24 hours without toothbrushing. After that, their dental surfaces will be stained, evaluated and the amount of dental plaque will be recorded. The first recording of the dental plaque will be registered and the brushing with each toothbrush model (at two different times, being these at least one week apart) was performed. Then, a second registration will be recorded. The measurement will be perfomed by visual assessment, according to the Plaque Index mentioned before. The index is based on the assessment of six areas of the dental surface; three in the buccal surface (mesio, middle and distobuccal) and three on the palatine / lingual surface following the same order (mesio, medium and disto). For each area a value according to the presence of plaque will be recorded. These values can be from 0 to 5. A statistical analysis will be performed to compare the amount of plaque removing after brushing with each toothbrush model.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startJun 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth CariesStudies 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
- Model description
- This is a study designed where all the participants will have to try the two devices that were being tested.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cristina de Souza Alves, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502538
- Sponsor's protocol ID
- CURAPROX5460-INDICATORPLUS
- Status last verified
- Apr 2018
- First submitted
- 29 Jan 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be published. Consent forms and participant information sheets will explain how data will be shared after the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes Models: Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus
- ClinicalTrials.gov ID
- NCT03502538
- Acronym / sponsor ID
- CURAPROX5460-INDICATORPLUS
- Conditions
- Tooth Caries, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
Objective: To compare the efficacy of Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus toothbrushes in dental plaque removal. Methods: 50 adult participants will be included in the sample. For a period of 24 hours (at two different times), they will be instructed to stop oral hygiene. During the final 4 hours, the interruption of consumption of foods and liquids will be recommended, and in smokers' case, the use of cigarettes. In two clinical visits (T0 and T1), volunteers will be asked to brush their teeth for 1 minute with Curaprox® (CS 5460 Ultra Soft) e Oral-B® (Indicator Plus) toothbrushes. Disclosure will be performed prior to and after brushing and the presence of plaque on the tooth surfaces will be evaluated. Turesky Modified Quigley Hein Plaque Index will be used for the plaque record. For statistical analysis, paired t tests will be performed to compare the effectiveness of toothbrushes and correlation test to assess whether the fact that the patient was aware of the toothbrush that will be used influenced in their performance.
Detailed description
For the study, 50 patients, between 18 and 55 years of age, of both sexes and healthy will be selected. For the study performance, volunteers will be instructed to stop their brushing for 23 to 25 hours before the first clinical visit. In addition, they will be also instructed to stop eating (solid foods and liquids) and to stop the use of cigarettes, if smoker, for 4 hours before evaluation. Prior to the study, a pilot study will be conducted at the University Hospital of Brasília for the researcher calibration using the Turesky Modified Quigley Hein Plaque Index, following the predetermined protocol.
A double-blind crossover study will be designed in which each volunteer will test two different models of toothbrushes. Prior to the beginning of the study, the brushes handle will be hidden with tape in a way that it will be not possible to see the toothbrush trademark. During the two visits, both brushes will be placed on the workbench and in the absence of the researcher, the participant will select one of the brushes. In the following visit, the same procedure will be performed and the participant will use the second brush. A period of washout of at least one week between the the first visit and the second visit will be done to obtain non-interference between results. No brush restriction will be imposed for the participant during this period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a study designed where all the participants will have to try the two devices that were being tested.
| Arm | Type | Receives |
|---|---|---|
| Curaprox 5460 Ultra Soft | Experimental | Device: Curaprox 5460 Ultra Soft, Device: Oral-B Indicator PlusBrushing with a Curaprox Ultra Soft 5460 toothbrush for one minute timed without orientations about brushing techniques and without supervision |
| Oral-B Indicator Plus | Active comparator | Device: Curaprox 5460 Ultra Soft, Device: Oral-B Indicator PlusBrushing with a Oral-B Indicator Plus toothbrush for one minute timed without orientations about brushing techniques and without supervision |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good oral health
- At least, 24 health teeth
Key exclusion criteria (1 listed)
- Those with any limitations that make it difficult for the dental examination or the performance of brushing, which use removable prostheses, orthodontic appliances, and/or that have malocclusions, and the presence of a gingival recess equal to or greater than 2mm
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 |
|---|---|---|
| Curaprox 5460 Ultra SoftThe toothbrush Curaprox 5460 Ultra Soft will be the tested toothbrush model, in order to asses its efficacy in plaque removal. Therefore, the study participants should brush their teeth using this toothbrush model, following the instructions of the investigator. From the data collect related in plaque removal the results will be arrived at. | Device | Curaprox 5460 Ultra Soft, Oral-B Indicator Plus |
| Oral-B Indicator PlusFollowing the same method of the Curaprox group intervention, the participants should brush their teeth using the Oral-B Indicator Plus toothbrush and based on the data collect, the results will be compared with the first group of intervention. | Device | Curaprox 5460 Ultra Soft, Oral-B Indicator Plus |
Primary outcome
Comparison of dental plaque removal between the toothbrushes Curaprox and Oral-B
Time frame: Five months
The participants should stay for 24 hours without toothbrushing. After that, their dental surfaces will be stained, evaluated and the amount of dental plaque will be recorded. The first recording of the dental plaque will be registered and the brushing with each toothbrush model (at two different times, being these at least one week apart) was performed. Then, a second registration will be recorded. The measurement will be perfomed by visual assessment, according to the Plaque Index mentioned before. The index is based on the assessment of six areas of the dental surface; three in the buccal surface (mesio, middle and distobuccal) and three on the palatine / lingual surface following the same order (mesio, medium and disto). For each area a value according to the presence of plaque will be recorded. These values can be from 0 to 5. A statistical analysis will be performed to compare the amount of plaque removing after brushing with each toothbrush model.
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 18 Apr 2018.
- Individual participant dataSharing planned: Yes. The results will be published. Consent forms and participant information sheets will explain how data will be shared after the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Curaprox 5460 Ultra Soft and Oral-B Indicator Plus in people with Tooth Caries and Dental Plaque, run by University of Brasilia.
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 2 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of dental plaque removal between the toothbrushes Curaprox and Oral-B (time frame: Five months). 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 18 Apr 2018.