Dental PlaquePhase 2NCT01986972
Supragingival Plaque Removal With and Without Dentifrice
A Phase 2 study testing Toothbrushing With Dentifrice and Toothbrushing Without Dentifrice in people with Dental Plaque, run by Franciscan University Center at 1 site in Brazil.
Trial summary
Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by brushing with and without conventional toothpaste. Settings and Design: Twenty-four students aged 17 to 28 years old participated in this randomized clinical trial. Read more about this study
- Who is it for?
- Ages 17 to 28 years
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Toothbrushing With Dentifrice and Toothbrushing Without Dentifrice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Nov 2010
- Phase
- Phase 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 17 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- students of both genders systemically healthy.
Who cannot join
- individuals who exhibited gingivitis (presence of gingival bleeding at any site);
- probing depth > 3mm and/or attachment loss >3mm at any site;
- using orthodontic appliance devices, dental prostheses, dental implants;
- presence of abrasions, restorations and/or carious lesions at cervical region;
- individuals who had less than 20 natural teeth.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Franciscan University Center
Santa Maria, Rio Grande do Sul, 97010-491
About this study
Official title: Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial
Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by brushing with and without conventional toothpaste. Settings and Design: Twenty-four students aged 17 to 28 years old participated in this randomized clinical trial.
Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of cessation of oral hygiene, Quigley \& Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by paired sample t test.
- Conditions
- Dental Plaque
- Being tested
- Toothbrushing With Dentifrice, Toothbrushing Without Dentifrice
- Keywords
- Toothbrushing, Dental plaque, Dentifrice, Oral hygiene
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrushing With DentifriceOther
Also called Brushed with multi bristle brush, Dentifrice closeUp
The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
Toothbrushing Without DentifriceOther
The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Then, dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
| Study group | Role | What they receive |
|---|---|---|
| Toothbrushing With Dentifrice | Active comparator | After 72 hours of absence oral hygiene, patients performed toothbrushing with common dentifrice. Receives: Other: Toothbrushing With Dentifrice |
| Toothbrushing Without Dentifrice | Experimental | After 72 hours of absence oral hygiene, patients performed toothbrushing without dentifrice. Receives: Other: Toothbrushing Without Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque
The presence of plaque was determined by Quigley and Hein (QH) (19) modified by Turesky index.
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJul 2009
- Primary completionSep 2010
- Study completionNov 2010
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franciscan University Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Pippi Antoniazzi, Franciscan University Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986972
- Sponsor's protocol ID
- RAntoniazzi
- Status last verified
- Nov 2013
- First submitted
- 9 Mar 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01986972
- Acronym / sponsor ID
- RAntoniazzi
- Conditions
- Dental Plaque
- Keywords
- Toothbrushing, Dental plaque, Dentifrice, Oral hygiene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Franciscan University CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Nov 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.
Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by brushing with and without conventional toothpaste. Settings and Design: Twenty-four students aged 17 to 28 years old participated in this randomized clinical trial.
Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of cessation of oral hygiene, Quigley \& Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by paired sample t test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothbrushing With Dentifrice | Active comparator | Other: Toothbrushing With DentifriceAfter 72 hours of absence oral hygiene, patients performed toothbrushing with common dentifrice. |
| Toothbrushing Without Dentifrice | Experimental | Other: Toothbrushing Without DentifriceAfter 72 hours of absence oral hygiene, patients performed toothbrushing without dentifrice. |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- students of both genders systemically healthy.
Key exclusion criteria (5 listed)
- individuals who exhibited gingivitis (presence of gingival bleeding at any site);
- probing depth > 3mm and/or attachment loss >3mm at any site;
- using orthodontic appliance devices, dental prostheses, dental implants;
- presence of abrasions, restorations and/or carious lesions at cervical region;
- individuals who had less than 20 natural teeth.
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 |
|---|---|---|
| Toothbrushing With DentifriceAlso: Brushed with multi bristle brush, Dentifrice closeUpThe participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice. | Other | Toothbrushing With Dentifrice |
| Toothbrushing Without DentifriceThe participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Then, dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice. | Other | Toothbrushing Without Dentifrice |
Primary outcome
Dental plaque
Time frame: Three days
The presence of plaque was determined by Quigley and Hein (QH) (19) modified by Turesky index.
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 19 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toothbrushing With Dentifrice and Toothbrushing Without Dentifrice in people with Dental Plaque, run by Franciscan University Center 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 5 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 19 Nov 2013. 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 phase mean?
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?
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 plaque (time frame: Three 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 19 Nov 2013.