Back to resultsEfficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electric toothbrush
Control
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility 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
Sites / Locations
- All Sum Research Center Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electric toothbrush and power interdental device
Electric toothbrush
Arm Description
Electric toothbrush and power interdental device
Electric toothbrush
Outcomes
Primary Outcome Measures
Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
Bleeding on Probing
Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks
Modified Gingival Index
Secondary Outcome Measures
Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.
Rustogi Modification of the Navy Plaque Index
Full Information
NCT ID
NCT04003298
First Posted
June 26, 2019
Last Updated
September 11, 2019
Sponsor
Water Pik, Inc.
Collaborators
All Sum Research Center Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04003298
Brief Title
Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.
Official Title
Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
July 26, 2019 (Actual)
Study Completion Date
August 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Water Pik, Inc.
Collaborators
All Sum Research Center Ltd.
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electric toothbrush and power interdental device
Arm Type
Experimental
Arm Description
Electric toothbrush and power interdental device
Arm Title
Electric toothbrush
Arm Type
Active Comparator
Arm Description
Electric toothbrush
Intervention Type
Device
Intervention Name(s)
Electric toothbrush
Intervention Description
Electric toothbrush and power interdental device
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Oscillating-rotating
Primary Outcome Measure Information:
Title
Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
Description
Bleeding on Probing
Time Frame
4 weeks
Title
Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks
Description
Modified Gingival Index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.
Description
Rustogi Modification of the Navy Plaque Index
Time Frame
pre & post, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Qaqish
Organizational Affiliation
All Sum Research Center Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
All Sum Research Center Ltd.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5N 6J2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.
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