Comparison of Two Interdental Cleaners | NCT03047759

Studies
Comparison of Two Interdental Cleaners

NCT03047759

Sponsor

All Sum Research Center Ltd.

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Gingivitis

Interventions

water flosser
air floss

Countries

Not provided

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

Aug 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 21, 2016Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 19, 2016Actual

First Submitted Date

Aug 17, 2016

First Submission Date that Met QC Criteria

Feb 7, 2017

First Posted Date

Feb 9, 2017Estimated

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

Feb 7, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Description Module

Brief Summary

Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

Detailed Description

This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention A	Active Comparator	water flosser	Device: water flosser
Intervention B	Active Comparator	air floss	Device: air floss

Interventions

Name	Type	Description	Arm Group Labels	Other Names
water flosser	Device	Powered	Intervention A
air floss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding upon probing	Bleeding upon probing	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Gingivitis	Modified Gingival \index	4 weeks
Plaque	Rustogi Modification of the Navy Plaque Index	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult
Non smoker
Available for 4-weeks
Able to provide written informed consent.
Minimum of 20 natural teeth.
Minimum requirement for plaque, gingivitis and bleeding.

Exclusion Criteria:

Medical condition
No antibiotics within 6 months of study start
Not on any medication (impact oral health).

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

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

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided