HealthyNCT02412358
Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
A study testing toothbrush in people with Healthy, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy. Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- May 2008to Jun 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having at least five teeth in each quadrant;
- no partial denture;
- no orthodontic banding or retention wires;
- no oral lesions or sites with probing pockets depth ≥ 5 mm;
- routine use of a manual toothbrush.
Who cannot join
- having any systematic disease which would influence the course of periodontal diseases or the response to the treatment
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
- Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.
- Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.
Read the detailed description
This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.
- Conditions
- Healthy
- Being tested
- toothbrush
- Keywords
- toothbrushing, plaque control, gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toothbrushDevice
Also called Pulsar, Crossaction, Butler toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Pulsar | Active comparator | Patients use Pulsar toothbrush for plaque removal Receives: Device: toothbrush |
| Crossaction | Active comparator | Patients use Crossaction toothbrush for plaque removal Receives: Device: toothbrush |
| Butler | Active comparator | Patients use Butler toothbrush for plaque removal Receives: Device: toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
it is an index used for scoring plaque accumulation
Measured: 2 weeks
Gingival index
it is an index used for scoring gingival inflammation
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Moeintaghavi, Mashhad University of Medical Sciences
- Investigators
- Amir Moeintaghavi, DDs., Msc., Principal investigator, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412358
- Sponsor's protocol ID
- 86394
- Status last verified
- Jan 2020
- First submitted
- 6 Apr 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
- ClinicalTrials.gov ID
- NCT02412358
- Acronym / sponsor ID
- 86394
- Conditions
- Healthy
- Keywords
- toothbrushing, plaque control, gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Apr 2015 (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.
- Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.
- Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.
Detailed description
This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulsar | Active comparator | Device: toothbrushPatients use Pulsar toothbrush for plaque removal |
| Crossaction | Active comparator | Device: toothbrushPatients use Crossaction toothbrush for plaque removal |
| Butler | Active comparator | Device: toothbrushPatients use Butler toothbrush for plaque removal |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- having at least five teeth in each quadrant;
- no partial denture;
- no orthodontic banding or retention wires;
- no oral lesions or sites with probing pockets depth ≥ 5 mm;
- routine use of a manual toothbrush.
Key exclusion criteria (2 listed)
- having any systematic disease which would influence the course of periodontal diseases or the response to the treatment
- smoking
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 |
|---|---|---|
| toothbrushAlso: Pulsar, Crossaction, Butler toothbrush | Device | Butler, Crossaction, Pulsar |
Primary outcome
Plaque Index
Time frame: 2 weeks
it is an index used for scoring plaque accumulation
Gingival index
Time frame: 2 weeks
it is an index used for scoring gingival inflammation
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 7 Jan 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.
Amir Moeintaghavi, DDs., Msc. principal investigator
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toothbrush in people with Healthy, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 7 Jan 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 Iran. 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?
Plaque Index (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 7 Jan 2020.