GingivitisNCT02836223
Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
A study testing Interdental cleaning device and Manual Tooth brush in people with Gingivitis, run by Water Pik, Inc. at 1 site in Canada.
Trial summary
This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation. 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?
- Interdental cleaning device and Manual Tooth brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Aug 2016
- 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
- Between 25 and 70 years of age
- 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
- Good general health and be a non-smoker
- A minimum of 50% bleeding on probing sites
- A minimum pre-brushing plaque score of 0.6
Show all 14Show fewer
- A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm
- 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
- Probing depth greater than 5 mm
- Systemic disease (ex. Diabetes, autoimmune disease)
- Advanced periodontitis
- Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
- 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
This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.
- Conditions
- Gingivitis
- Being tested
- Interdental cleaning device, Manual Tooth brush
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental cleaning deviceDevice
Water Flosser
Manual Tooth brushDevice
Control
| Study group | Role | What they receive |
|---|---|---|
| Interdental device | Experimental | Water Flosser Receives: Device: Interdental cleaning device; Device: Manual Tooth brush |
| Toothbrush | Other | Control Receives: Device: Manual Tooth brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of gingival bleeding
Measured: 4 weeks
Secondary outcomes (2)
Reduction of gingival inflammation
Measured: 4 weeks
Reduction in dental plaque
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
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
- 72 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836223
- Sponsor's protocol ID
- 16WFVSMTB2016
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
- ClinicalTrials.gov ID
- NCT02836223
- Acronym / sponsor ID
- 16WFVSMTB2016
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Water Pik, Inc.Industry (pharma, biotech, devices)
- Collaborators
- All Sum Research Center Ltd.
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Jul 2016 (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.
This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdental device | Experimental | Device: Interdental cleaning device, Device: Manual Tooth brushWater Flosser |
| Toothbrush | Other | Device: Manual Tooth brushControl |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Between 25 and 70 years of age
- 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
- Good general health and be a non-smoker
- A minimum of 50% bleeding on probing sites
Key exclusion criteria (7 listed)
- Probing depth greater than 5 mm
- Systemic disease (ex. Diabetes, autoimmune disease)
- Advanced periodontitis
- Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
- 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 |
|---|---|---|
| Interdental cleaning deviceWater Flosser | Device | Interdental device |
| Manual Tooth brushControl | Device | Interdental device, Toothbrush |
Primary outcome
Reduction of gingival bleeding
Time frame: 4 weeks
2 secondary outcomes
Reduction of gingival inflammation
Time frame: 4 weeks
Reduction in dental plaque
Time frame: 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 1 Nov 2016.
- 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.
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 Interdental cleaning device and Manual Tooth brush 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 14 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 1 Nov 2016. 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?
Reduction of gingival bleeding (time frame: 4 weeks). 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 1 Nov 2016.