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Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836223
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
All Sum Research Center Ltd.
Information provided by (Responsible Party):
Water Pik, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Gingivitis Device: Interdental cleaning device Device: Manual Tooth brush Not Applicable

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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




Primary Outcome Measures :
  1. Reduction of gingival bleeding [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Reduction of gingival inflammation [ Time Frame: 4 weeks ]
  2. Reduction in dental plaque [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
All Sum Research Center Ltd.
Mississauga, Ontario, Canada, L4W 0C2
Sponsors and Collaborators
Water Pik, Inc.
All Sum Research Center Ltd.
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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
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases