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

Water Pik

Status: Completed

Conditions: Gingivitis

Treatments: Device: Manual Tooth brush; Device: Interdental cleaning device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02836223

16WFVSMTB2016

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Interdental device

Experimental group

Description:

Water Flosser

Treatment:

Device: Interdental cleaning device

Device: Manual Tooth brush

Toothbrush

Other group

Description:

Control

Treatment:

Device: Manual Tooth brush