GingivitisNCT03624647
A Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush
A study testing Power toothbrush and Manual toothbrush in people with Gingivitis and Dental Plaque, run by Procter and Gamble at 1 site in Canada.
Trial summary
The objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Power toothbrush and Manual toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2018to 14 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give written informed consent prior to study participation and be given a signed copy of their informed consent form
- be at least 18 years of age and typically use a manual toothbrush;
- be in good general health as determined by the investigator/designee based on a review/update of their medical history;
- possess a minimum of 16 natural teeth with facial and lingual scorable surfaces;
- have a Baseline pre-brushing MGI score of at least 1.75;
- have a Baseline pre-brushing RMNPI score of greater than 0.5;
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- have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index) for Baseline pre-brushing;
- agree not to participate in any other oral care study for the duration of this study;
- agree to not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study;
- agree to refrain from using any non-study oral hygiene products for the study duration;
- agree to return for all their scheduled visits and to follow all study procedures;
- refrained from brushing their teeth or from performing any other oral hygiene procedures anytime within the 12 hours prior to their morning brushing and agree to follow these same restrictions prior to all visits except (the Week 1 p.m. visit);
- refrained from any oral hygiene, eating, drinking* (except small sips of water), chewing gum, and tobacco use for at least 3 hours but not more than 6 hours prior to this visit and agree to follow these same restrictions prior to all p.m. visits.
Who cannot join
- a condition requiring the need for antibiotic premedication prior to dental procedures;
- severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession;
- teeth that are grossly carious, fully crowned, or extensively restored;
- active treatment for the following conditions: periodontitis, cancer, or a seizure disorder;
- report to be nursing or pregnant, or intend to become pregnant any time during the course of this study;
- taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks;
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- have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device;
- oral/gum surgery within the previous two months;
- a disease or condition that could possibly interfere with examination/procedures or with the subject's safe completion of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8-Week Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush in the Reduction of Gingivitis and Plaque
The objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Power toothbrush, Manual toothbrush
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power toothbrushDevice
Experimental power toothbrush
Manual toothbrushDevice
Marketed manual toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Power toothbrush | Experimental | Not described Receives: Device: Power toothbrush |
| Manual toothbrush | Placebo comparator | Not described Receives: Device: Manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Gingival Index
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Measured: Baseline
Modified Gingival Index
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Measured: Week 1
Modified Gingival Index
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Measured: Week 8
Rustogi Modification of the Navy Plaque Index
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Measured: Baseline
Rustogi Modification of the Navy Plaque Index
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Measured: Week 1
Rustogi Modification of the Navy Plaque Index
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start9 Jul 2018
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624647
- Sponsor's protocol ID
- 2018030
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2018
- Last updated
- 27 Sep 2018
- 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 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush in the Reduction of Gingivitis and Plaque
- ClinicalTrials.gov ID
- NCT03624647
- Acronym / sponsor ID
- 2018030
- Conditions
- Gingivitis, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 10 Aug 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.
The objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power toothbrush | Experimental | Device: Power toothbrush |
| Manual toothbrush | Placebo comparator | Device: Manual toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- give written informed consent prior to study participation and be given a signed copy of their informed consent form
- be at least 18 years of age and typically use a manual toothbrush;
- be in good general health as determined by the investigator/designee based on a review/update of their medical history;
- possess a minimum of 16 natural teeth with facial and lingual scorable surfaces;
- have a Baseline pre-brushing MGI score of at least 1.75;
Key exclusion criteria (9 listed)
- a condition requiring the need for antibiotic premedication prior to dental procedures;
- severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession;
- teeth that are grossly carious, fully crowned, or extensively restored;
- active treatment for the following conditions: periodontitis, cancer, or a seizure disorder;
- report to be nursing or pregnant, or intend to become pregnant any time during the course of this study;
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 |
|---|---|---|
| Power toothbrushExperimental power toothbrush | Device | Power toothbrush |
| Manual toothbrushMarketed manual toothbrush | Device | Manual toothbrush |
Primary outcome
Modified Gingival Index
Time frame: Baseline
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Modified Gingival Index
Time frame: Week 1
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Modified Gingival Index
Time frame: Week 8
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Rustogi Modification of the Navy Plaque Index
Time frame: Baseline
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Rustogi Modification of the Navy Plaque Index
Time frame: Week 1
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Rustogi Modification of the Navy Plaque Index
Time frame: Week 8
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
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 27 Sep 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.
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 study testing Power toothbrush and Manual toothbrush in people with Gingivitis and Dental Plaque, run by Procter and Gamble at 1 site in Canada.
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 13 inclusion and 9 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 27 Sep 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Modified Gingival Index (time frame: Baseline). The study lists 6 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 27 Sep 2018.