Soft Tissue InjuriesNCT03049761
Water Flosser vs String Floss vs Manual Toothbrush Safety
A study testing Water Flosser, String Floss and Manual Toothbrush in people with Soft Tissue Injuries, run by All Sum Research Center Ltd..
Trial summary
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Water Flosser, String Floss and Manual Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 23 Feb 2017
- 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
- Written consent prior to participation
- Good general health and non smoker
- Have scorable Ramfjord's teeth
Who cannot join
- Probing depth >4mm on Ramfjord's teeth
- Moderate to severe gingivitis
- Advanced periodontitis
- Medications that impact soft tissue.
About this study
Official title: Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Read the detailed description
This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.
- Conditions
- Soft Tissue Injuries
- Being tested
- Water Flosser, String Floss, Manual Toothbrush
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water FlosserDevice
Power interdental cleaner
String FlossDevice
Mechanical interdental cleaner
Manual ToothbrushDevice
ADA standard soft bristle toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Water Flosser | Active comparator | Power interdental Cleaning Device Receives: Device: Water Flosser |
| String floss | Active comparator | Manual interdental cleaning device Receives: Device: String Floss |
| Manual Toothbrush | Active comparator | ADA standard manual toothbrush Receives: Device: Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Levels
Measurement from the junction Epithelium to the cemento enamel junction
Measured: 6 weeks
Secondary outcomes (1)
Probing pocket depth
Measurement from the junction Epithelium to the free gingival margin
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start9 Jan 2017
- Primary completion20 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- All Sum Research Center Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Water Pik, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049761
- Sponsor's protocol ID
- 2017-WP-1
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
- ClinicalTrials.gov ID
- NCT03049761
- Acronym / sponsor ID
- 2017-WP-1
- Conditions
- Soft Tissue Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- All Sum Research Center Ltd.University, hospital or other
- Collaborators
- Water Pik, Inc.
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 10 Feb 2017 (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.
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Detailed description
This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
| Arm | Type | Receives |
|---|---|---|
| Water Flosser | Active comparator | Device: Water FlosserPower interdental Cleaning Device |
| String floss | Active comparator | Device: String FlossManual interdental cleaning device |
| Manual Toothbrush | Active comparator | Device: Manual ToothbrushADA standard manual toothbrush |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent prior to participation
- Good general health and non smoker
- Have scorable Ramfjord's teeth
Key exclusion criteria (4 listed)
- Probing depth >4mm on Ramfjord's teeth
- Moderate to severe gingivitis
- Advanced periodontitis
- Medications that impact soft tissue.
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 FlosserPower interdental cleaner | Device | Water Flosser |
| String FlossMechanical interdental cleaner | Device | String floss |
| Manual ToothbrushADA standard soft bristle toothbrush | Device | Manual Toothbrush |
Primary outcome
Clinical Attachment Levels
Time frame: 6 weeks
Measurement from the junction Epithelium to the cemento enamel junction
1 secondary outcome
Probing pocket depth
Time frame: 6 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 10 Jan 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.
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, String Floss and Manual Toothbrush in people with Soft Tissue Injuries, 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 3 inclusion and 4 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 10 Jan 2019. 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?
Clinical Attachment Levels (time frame: 6 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 10 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.