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

Gingivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836223
• Other study ID #: 16WFVSMTB2016
• Status: Completed
• Phase: N/A
• First received: July 14, 2016
• Last updated: October 31, 2016
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Water Pik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: All Sum Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Interdental cleaning device
Water Flosser
• Manual Tooth brush
Control

Locations

Country	Name	City	State
Canada	All Sum Research Center Ltd.	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Water Pik, Inc.	All Sum Research Center Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of gingival bleeding		4 weeks	No
Secondary	Reduction of gingival inflammation		4 weeks	No
Secondary	Reduction in dental plaque		4 weeks	No