Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
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ClinicalTrials.gov Identifier: NCT02836223 |
Recruitment Status :
Completed
First Posted : July 18, 2016
Last Update Posted : November 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gingivitis | Device: Interdental cleaning device Device: Manual Tooth brush | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | July 2016 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Interdental device
Water Flosser
|
Device: Interdental cleaning device
Water Flosser Device: Manual Tooth brush Control |
Toothbrush
Control
|
Device: Manual Tooth brush
Control |
- Reduction of gingival bleeding [ Time Frame: 4 weeks ]
- Reduction of gingival inflammation [ Time Frame: 4 weeks ]
- Reduction in dental plaque [ Time Frame: 4 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836223
Canada, Ontario | |
All Sum Research Center Ltd. | |
Mississauga, Ontario, Canada, L4W 0C2 |
Responsible Party: | Water Pik, Inc. |
ClinicalTrials.gov Identifier: | NCT02836223 |
Other Study ID Numbers: |
16WFVSMTB2016 |
First Posted: | July 18, 2016 Key Record Dates |
Last Update Posted: | November 1, 2016 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Gingivitis Gingival Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases |