CariestoothbrushingNCT01501357
Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control
A study testing modified toothbrush with multilevel filaments and cross toothbrushing in people with Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- modified toothbrush with multilevel filaments and cross toothbrushing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Dec 2014
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- erupting primary permanent molar
Who cannot join
- caries ( ICDAS 4,5 and 6),
- enamel defects,
- sealant,
- restoration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control in Erupting Primary Permanent Molars - Randomized Clinical Trial Abbreviated Over 24 Months
The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.
Read the detailed description
220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.
- Conditions
- Caries
- Being tested
- modified toothbrush with multilevel filaments, cross toothbrushing
- Keywords
- caries, primary molars, plaque, toothbrushing
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified toothbrush with multilevel filamentsBehavioural
Also called stages, oral b
After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.
cross toothbrushingBehavioural
Also called buccal-lingual technique
Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique
| Study group | Role | What they receive |
|---|---|---|
| multilevel filaments toothbrush | Experimental | Children will brush with anteroposterior toothbrushing and a modified toothbrush (multilevel filaments) Receives: Behavioral: modified toothbrush with multilevel filaments |
| cross toothbrushing | Active comparator | Children will brush with cross toothbrushing. Receives: Behavioral: cross toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental caries
Measured: 24 months
Secondary outcomes (1)
dental plaque
Dental plaque accumulation after short and long term analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501357
- Sponsor's protocol ID
- 001
- Acronym
- toothbrushing
- Status last verified
- Mar 2018
- First submitted
- 20 Dec 2011
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control in Erupting Primary Permanent Molars - Randomized Clinical Trial Abbreviated Over 24 Months
- ClinicalTrials.gov ID
- NCT01501357
- Acronym / sponsor ID
- toothbrushing / 001
- Conditions
- Caries
- Keywords
- caries, primary molars, plaque, toothbrushing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Dec 2011 (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 aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.
Detailed description
220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multilevel filaments toothbrush | Experimental | Behavioral: modified toothbrush with multilevel filamentsChildren will brush with anteroposterior toothbrushing and a modified toothbrush (multilevel filaments) |
| cross toothbrushing | Active comparator | Behavioral: cross toothbrushingChildren will brush with cross toothbrushing. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- erupting primary permanent molar
Key exclusion criteria (4 listed)
- caries ( ICDAS 4,5 and 6),
- enamel defects,
- sealant,
- restoration
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 |
|---|---|---|
| modified toothbrush with multilevel filamentsAlso: stages, oral bAfter the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior. | Behavioural | multilevel filaments toothbrush |
| cross toothbrushingAlso: buccal-lingual techniqueChildren allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique | Behavioural | cross toothbrushing |
Primary outcome
dental caries
Time frame: 24 months
1 secondary outcome
dental plaque
Time frame: 24 months
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 21 Mar 2018.
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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.
Mariana M Braga, 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 modified toothbrush with multilevel filaments and cross toothbrushing in people with Caries, run by University of Sao Paulo 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 1 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 21 Mar 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. 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?
dental caries (time frame: 24 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 21 Mar 2018.