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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02836223

Enrollment

Registered

2016-07-18

Start date

2016-07-31

Completion date

2016-08-31

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

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.

Interventions

DEVICEInterdental cleaning device

Water Flosser

DEVICEManual Tooth brush

Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Reduction of gingival bleeding	4 weeks

Secondary

Measure	Time frame
Reduction of gingival inflammation	4 weeks
Reduction in dental plaque	4 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026