GingivitisNCT03047759
Comparison of Two Interdental Cleaners
A study testing water flosser and air floss in people with Gingivitis, run by All Sum Research Center Ltd..
Trial summary
Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding. 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?
- water flosser and air floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2016to 19 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
- Healthy adult
- Non smoker
- Available for 4-weeks
- Able to provide written informed consent.
- Minimum of 20 natural teeth.
- Minimum requirement for plaque, gingivitis and bleeding.
Who cannot join
- Medical condition
- No antibiotics within 6 months of study start
- Not on any medication (impact oral health).
About this study
Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.
Read the detailed description
This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.
- Conditions
- Gingivitis
- Being tested
- water flosser, air floss
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water flosserDevice
Powered
air flossDevice
Powered
| Study group | Role | What they receive |
|---|---|---|
| Intervention A | Active comparator | water flosser Receives: Device: water flosser |
| Intervention B | Active comparator | air floss Receives: Device: air floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding upon probing
Bleeding upon probing
Measured: 4 weeks
Secondary outcomes (2)
Gingivitis
Modified Gingival \index
Measured: 4 weeks
Plaque
Rustogi Modification of the Navy Plaque Index
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 posted9 Feb 2017 (estimated)
- Study start21 Jul 2016
- Primary completionAug 2016
- Study completion19 Aug 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- All Sum Research Center Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047759
- Sponsor's protocol ID
- 2016-WP-2
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Interdental Cleaners
- ClinicalTrials.gov ID
- NCT03047759
- Acronym / sponsor ID
- 2016-WP-2
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- All Sum Research Center Ltd.University, hospital or other
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 9 Feb 2017 (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.
Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.
Detailed description
This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention A | Active comparator | Device: water flosserwater flosser |
| Intervention B | Active comparator | Device: air flossair floss |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult
- Non smoker
- Available for 4-weeks
- Able to provide written informed consent.
- Minimum of 20 natural teeth.
Key exclusion criteria (3 listed)
- Medical condition
- No antibiotics within 6 months of study start
- Not on any medication (impact oral health).
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 |
|---|---|---|
| water flosserPowered | Device | Intervention A |
| air flossPowered | Device | Intervention B |
Primary outcome
Bleeding upon probing
Time frame: 4 weeks
Bleeding upon probing
2 secondary outcomes
Gingivitis
Time frame: 4 weeks
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 9 Feb 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing water flosser and air floss in people with Gingivitis, run by All Sum Research Center Ltd..
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 6 inclusion and 3 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Bleeding upon probing (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 9 Feb 2017.