Evaluation of the Addition of an Interdental Cleaning Dev... | NCT02836223

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

NCT02836223

Sponsor

Water Pik, Inc.

Status

Completed

Last Update Posted

Nov 1, 2016Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Gingivitis

Interventions

Interdental cleaning device
Manual Tooth brush

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jul 14, 2016

First Submission Date that Met QC Criteria

Jul 14, 2016

First Posted Date

Jul 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Name	Class
All Sum Research Center Ltd.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interdental device	Experimental	Water Flosser	Device: Interdental cleaning device Device: Manual Tooth brush
Toothbrush	Other	Control	Device: Manual Tooth brush

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interdental cleaning device	Device	Water Flosser	Interdental device

Measure	Description	Time Frame
Reduction of gingival bleeding		4 weeks

Measure	Description	Time Frame
Reduction of gingival inflammation		4 weeks
Reduction in dental plaque		4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
All Sum Research Center Ltd.		Mississauga	Ontario	L4W 0C2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases