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

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Device: Manual Tooth brush; Device: Interdental cleaning device

• Registration Number: NCT02836223
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-18
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toothbrush	Manual Tooth brush	Control
Interdental device	Manual Tooth brush	Water Flosser
Interdental device	Interdental cleaning device	Water Flosser

Primary Outcome Measures

Name	Time	Method
Reduction of gingival bleeding	4 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction of gingival inflammation	4 weeks
Reduction in dental plaque	4 weeks

Trial Locations

Locations (1)

All Sum Research Center Ltd.; 🇨🇦 Mississauga, Ontario, Canada