GingivitisNCT04003298
Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.
A study testing Electric toothbrush in people with Gingivitis, run by Water Pik, Inc. at 1 site in Canada.
Trial summary
The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Electric toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2019to 23 Aug 2019
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between 20 and 70 years of age
- Be able to provide written informed consent prior to participation
- Agree to not participate in any other oral/dental products clinical study for the study duration
- Be in good general health and be a non-smoker
- Have 50% bleeding on probing sites (moderate gingivitis)
- Have no probing depths greater than 4 mm
Show all 13Show fewer
- Have a minimum of 20 teeth (not including 3rd molars)
- No partial dentures, orthodontic brackets, wires or other appliances
- Agree to refrain from the use of any non-study dental device or oral care product for the study duration
- Agree to return for the scheduled visits and follow study procedures
- Agree to delay dental prophylaxis until study completion
- Have a minimum pre-brushing plaque score of 0.6
- Have a minimum of 1.75 gingivitis score
Who cannot join
- Have probing depth greater than 4 mm
- Have a systemic disease (ex. Diabetes, autoimmune disease)
- Have advanced periodontitis
- Taking medication that can influence gingival health (ex. Dilantin, Procardia (calcium channel blockers), Cyclosporine, anticoagulants)
- Have orthodontic appliances or removable partial dentures
- Pregnant at time of study
- Use of antibiotics within 6 months of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.
The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks.
Read the detailed description
Data will be analyzed and reported as mean. The target population is approximately 70 healthy adult volunteers. There will be two groups with a total of 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, patients will be randomly assigned in a 1:1 ratio to receive either:
With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.
The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.
Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre \& post, 2 weeks and 4 weeks (=/- 2 days)
Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed up.
Subjects will complete a questionnaire at the completion of the study.
- Conditions
- Gingivitis
- Being tested
- Electric toothbrush, Control
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric toothbrushDevice
Electric toothbrush and power interdental device
ControlDevice
Oscillating-rotating
| Study group | Role | What they receive |
|---|---|---|
| Electric toothbrush and power interdental device | Experimental | Electric toothbrush and power interdental device Receives: Device: Electric toothbrush |
| Electric toothbrush | Active comparator | Electric toothbrush Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
Bleeding on Probing
Measured: 4 weeks
Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks
Modified Gingival Index
Measured: 4 weeks
Secondary outcomes (1)
Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.
Rustogi Modification of the Navy Plaque Index
Measured: pre & post, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start26 Jun 2019
- Primary completion26 Jul 2019
- Study completion23 Aug 2019
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Water Pik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- All Sum Research Center Ltd.
- Responsible party
- Sponsor
- Investigators
- Jimmy Qaqish, Study director, All Sum Research Center Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003298
- Sponsor's protocol ID
- 26ORWF2019
- Status last verified
- Sep 2019
- First submitted
- 26 Jun 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04003298
- Acronym / sponsor ID
- 26ORWF2019
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Water Pik, Inc.Industry (pharma, biotech, devices)
- Collaborators
- All Sum Research Center Ltd.
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 1 Jul 2019 (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 study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks.
Detailed description
Data will be analyzed and reported as mean. The target population is approximately 70 healthy adult volunteers. There will be two groups with a total of 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, patients will be randomly assigned in a 1:1 ratio to receive either:
With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.
The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.
Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre \& post, 2 weeks and 4 weeks (=/- 2 days)
Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed up.
Subjects will complete a questionnaire at the completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric toothbrush and power interdental device | Experimental | Device: Electric toothbrushElectric toothbrush and power interdental device |
| Electric toothbrush | Active comparator | Device: ControlElectric toothbrush |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be between 20 and 70 years of age
- Be able to provide written informed consent prior to participation
- Agree to not participate in any other oral/dental products clinical study for the study duration
- Be in good general health and be a non-smoker
- Have 50% bleeding on probing sites (moderate gingivitis)
Key exclusion criteria (7 listed)
- Have probing depth greater than 4 mm
- Have a systemic disease (ex. Diabetes, autoimmune disease)
- Have advanced periodontitis
- Taking medication that can influence gingival health (ex. Dilantin, Procardia (calcium channel blockers), Cyclosporine, anticoagulants)
- Have orthodontic appliances or removable partial dentures
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 |
|---|---|---|
| Electric toothbrushElectric toothbrush and power interdental device | Device | Electric toothbrush and power interdental device |
| ControlOscillating-rotating | Device | Electric toothbrush |
Primary outcome
Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
Time frame: 4 weeks
Bleeding on Probing
Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks
Time frame: 4 weeks
Modified Gingival Index
1 secondary outcome
Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.
Time frame: pre & post, 4 weeks
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 16 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Jimmy Qaqish study director
All Sum Research Center Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric toothbrush in people with Gingivitis, run by Water Pik, Inc. 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 7 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 16 Sep 2019. 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. 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?
Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks. (time frame: 4 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 16 Sep 2019.