search
Back to results

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

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interdental cleaning device
Manual Tooth brush
Sponsored by
Water Pik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • All Sum Research Center Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Interdental device

Toothbrush

Arm Description

Water Flosser

Control

Outcomes

Primary Outcome Measures

Reduction of gingival bleeding

Secondary Outcome Measures

Reduction of gingival inflammation
Reduction in dental plaque

Full Information

First Posted
July 14, 2016
Last Updated
October 31, 2016
Sponsor
Water Pik, Inc.
Collaborators
All Sum Research Center Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02836223
Brief Title
Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (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

Data Monitoring Committee
No

5. Study Description

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.

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
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interdental device
Arm Type
Experimental
Arm Description
Water Flosser
Arm Title
Toothbrush
Arm Type
Other
Arm Description
Control
Intervention Type
Device
Intervention Name(s)
Interdental cleaning device
Intervention Description
Water Flosser
Intervention Type
Device
Intervention Name(s)
Manual Tooth brush
Intervention Description
Control
Primary Outcome Measure Information:
Title
Reduction of gingival bleeding
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Reduction of gingival inflammation
Time Frame
4 weeks
Title
Reduction in dental plaque
Time Frame
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: 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
Facility Information:
Facility Name
All Sum Research Center Ltd.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 0C2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs