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Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush 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: NCT04003298
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
All Sum Research Center Ltd.
Information provided by (Responsible Party):
Water Pik, Inc.

Brief Summary:
The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks.

Condition or disease Intervention/treatment Phase
Gingivitis Device: Electric toothbrush Device: Control Not Applicable

Detailed Description:

Data will be analyzed and reported as mean. The target population is approximately 70 healthy adult volunteers. There will be two groups with a total of 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, patients will be randomly assigned in a 1:1 ratio to receive either:

With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.

The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.

Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre & post, 2 weeks and 4 weeks (=/- 2 days)

Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed up.

Subjects will complete a questionnaire at the completion of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.
Actual Study Start Date : June 26, 2019
Actual Primary Completion Date : July 26, 2019
Actual Study Completion Date : August 23, 2019

Arm Intervention/treatment
Experimental: Electric toothbrush and power interdental device
Electric toothbrush and power interdental device
Device: Electric toothbrush
Electric toothbrush and power interdental device

Active Comparator: Electric toothbrush
Electric toothbrush
Device: Control
Oscillating-rotating




Primary Outcome Measures :
  1. Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks. [ Time Frame: 4 weeks ]
    Bleeding on Probing

  2. Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks [ Time Frame: 4 weeks ]
    Modified Gingival Index


Secondary Outcome Measures :
  1. Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks. [ Time Frame: pre & post, 4 weeks ]
    Rustogi Modification of the Navy Plaque Index



Information from the National Library of Medicine

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.


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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:

  • Be between 20 and 70 years of age
  • Be 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
  • Be in good general health and be a non-smoker
  • Have 50% bleeding on probing sites (moderate gingivitis)
  • Have no probing depths greater than 4 mm
  • Have 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:

  • Have probing depth greater than 4 mm
  • Have a systemic disease (ex. Diabetes, autoimmune disease)
  • Have advanced periodontitis
  • Taking medication that can influence gingival health (ex. Dilantin, Procardia (calcium channel blockers), Cyclosporine, anticoagulants)
  • Have 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): NCT04003298


Locations
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Canada, Ontario
All Sum Research Center Ltd.
Mississauga, Ontario, Canada, L5N 6J2
Sponsors and Collaborators
Water Pik, Inc.
All Sum Research Center Ltd.
Investigators
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Study Director: Jimmy Qaqish All Sum Research Center Ltd.
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Responsible Party: Water Pik, Inc.
ClinicalTrials.gov Identifier: NCT04003298    
Other Study ID Numbers: 26ORWF2019
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases