Dental PlaquePhase 1/2NCT04216069
Efficacy of Different Toothbrushes and Hygiene Regimen
A Phase 1/2 study testing Total 12 regimen and Toothbrushing alone in people with Dental Plaque and Halitosis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
To evaluate: 1) Evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. The Group 1 will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash, and the other Group will use Colgate Ultrasoft… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Halitosis
- What is being tested?
- Total 12 regimen and Toothbrushing alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2021to 25 Dec 2021
- Phase
- Phase 1/2
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Good general health;
- Age 12 to 17;
- Absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene.
Who cannot join
- Active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. If these teeth are not present, adjacent teeth may be considered;
- Teeth with formation defects and dental crowding;
- Periodontal disease (tooth mobility > 2 mm, pocket > 5 mm, gingivitis);
- Parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance;
- Volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments;
- Pregnant volunteers;
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- Use of medications that alter gingival health, such as antibiotics, in the previous three months;
- Use of mouthwash or toothpaste containing products for the control of biofilm;
- Smokers;
- Systemic disease (diabetes).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metropolitana de Santos
Santos, São Paulo, 11045-401
Caroline M Moriyama, PhD, +55 13 32283400, caroline.cmm@hotmail.com
About this study
Official title: Evaluation of the Efficacy of a Commercially Available Regimen Versus Brushing Alone on Established Plaque and Gingivitis on Adolescents: Study Protocol for a Randomized, Controlled, Blind Clinical Trial
To evaluate: 1) Evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. The Group 1 will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash, and the other Group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste; 2) The level of halitosis. Two calibrated and blinded examiners (Cohen Kappa 85%) will evaluate the gingival condition using the visible plaque indices, a simplified oral hygiene index - IHOS and gingival bleeding index, with the aid of a WHO probe. For the evaluation of halitosis levels, all individuals will respond to a questionnaire regarding personal data, general and oral health, which includes hygiene habits and received previous guidelines for the procedures to be performed in the second moment. At the next consultation, subjects will be assessed clinically for halitosis using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan), in addition to the evaluation of the tongue flap index (ISL), pH and salivary flow. The evaluations will be in the following periods: baseline, 1, 3 and 6 months of brushing. Data will be submitted to descriptive statistical analysis to demonstrate the distributions frequency of biofilm indices and gingival bleeding. The differences in the criteria evaluated will be submitted to Fisher's exact test (α = 0.05) and their performance at different times will be evaluated by the Mann-Whitney test (α = 0.05).
- Conditions
- Dental Plaque, Halitosis
- Being tested
- Total 12 regimen, Toothbrushing alone
- Medical subject headings
- Dental Plaque, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total 12 regimenOther
The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Subjects from the Group 1 will use a regimen with Colgate Total 12 toothpaste + Plax mouthwash + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products.
There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products.
Toothbrushing aloneOther
The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Group 2 will use Colgate Cavity Protection Toothpaste + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products.
There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products.
| Study group | Role | What they receive |
|---|---|---|
| Total 12 regimen group | Experimental | This group will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash. Receives: Other: Total 12 regimen |
| Tooth brushing alone group | Experimental | This group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste. Receives: Other: Toothbrushing alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change in biofilm index
The gingival health assessments will be performed through a visual examination for the determination of the visible plaque index, gingival bleeding and oral health at baseline as well as after the use of brush.
Measured: Baseline, after 1, 3 and 6 months of toothbrushing.
Secondary outcomes (1)
Change in halitosis index
Halitosis index using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan).
Measured: Baseline, after 1, 3 and 6 months of toothbrushing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start5 Jan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion25 Dec 2021 (estimated)
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216069
- Sponsor's protocol ID
- Toothbrushes
- Status last verified
- Sep 2020
- First submitted
- 18 Dec 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Commercially Available Regimen Versus Brushing Alone on Established Plaque and Gingivitis on Adolescents: Study Protocol for a Randomized, Controlled, Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04216069
- Acronym / sponsor ID
- Toothbrushes
- Conditions
- Dental Plaque, Halitosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 5 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 2 Jan 2020 (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.
To evaluate: 1) Evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. The Group 1 will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash, and the other Group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste; 2) The level of halitosis. Two calibrated and blinded examiners (Cohen Kappa 85%) will evaluate the gingival condition using the visible plaque indices, a simplified oral hygiene index - IHOS and gingival bleeding index, with the aid of a WHO probe. For the evaluation of halitosis levels, all individuals will respond to a questionnaire regarding personal data, general and oral health, which includes hygiene habits and received previous guidelines for the procedures to be performed in the second moment. At the next consultation, subjects will be assessed clinically for halitosis using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan), in addition to the evaluation of the tongue flap index (ISL), pH and salivary flow. The evaluations will be in the following periods: baseline, 1, 3 and 6 months of brushing. Data will be submitted to descriptive statistical analysis to demonstrate the distributions frequency of biofilm indices and gingival bleeding. The differences in the criteria evaluated will be submitted to Fisher's exact test (α = 0.05) and their performance at different times will be evaluated by the Mann-Whitney test (α = 0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total 12 regimen group | Experimental | Other: Total 12 regimenThis group will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash. |
| Tooth brushing alone group | Experimental | Other: Toothbrushing aloneThis group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Good general health;
- Age 12 to 17;
- Absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene.
Key exclusion criteria (10 listed)
- Active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. If these teeth are not present, adjacent teeth may be considered;
- Teeth with formation defects and dental crowding;
- Periodontal disease (tooth mobility > 2 mm, pocket > 5 mm, gingivitis);
- Parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance;
- Volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments;
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 |
|---|---|---|
| Total 12 regimenThe volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Subjects from the Group 1 will use a regimen with Colgate Total 12 toothpaste + Plax mouthwash + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products. There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products. | Other | Total 12 regimen group |
| Toothbrushing aloneThe volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Group 2 will use Colgate Cavity Protection Toothpaste + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products. There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products. | Other | Tooth brushing alone group |
Primary outcome
Evaluation of change in biofilm index
Time frame: Baseline, after 1, 3 and 6 months of toothbrushing.
The gingival health assessments will be performed through a visual examination for the determination of the visible plaque index, gingival bleeding and oral health at baseline as well as after the use of brush.
1 secondary outcome
Change in halitosis index
Time frame: Baseline, after 1, 3 and 6 months of toothbrushing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Total 12 regimen and Toothbrushing alone in people with Dental Plaque and Halitosis, run by University of Nove de Julho 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 10 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: status not confirmed, as of the sponsor's last update on 21 Sep 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of change in biofilm index (time frame: Baseline, after 1, 3 and 6 months of toothbrushing.). 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 Sep 2020.