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Comparison of Two Interdental Cleaners

Primary Purpose

Gingivitis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

water flosser

air floss

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intervention A

Intervention B

Arm Description

water flosser

air floss

Outcomes

Primary Outcome Measures

Bleeding upon probing

Secondary Outcome Measures

Gingivitis

Modified Gingival \index

Plaque

Rustogi Modification of the Navy Plaque Index

Full Information

NCT ID

NCT03047759

First Posted

August 17, 2016

Last Updated

February 7, 2017

Sponsor

All Sum Research Center Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03047759

Brief Title

Comparison of Two Interdental Cleaners

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

July 21, 2016 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

All Sum Research Center Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention A

Arm Type

Active Comparator

Arm Description

water flosser

Arm Title

Intervention B

Arm Type

Active Comparator

Arm Description

air floss

Intervention Type

Device

Intervention Name(s)

water flosser

Intervention Description

Powered

Intervention Type

Device

Intervention Name(s)

air floss

Intervention Description

Powered

Primary Outcome Measure Information:

Title

Bleeding upon probing

Description

Bleeding upon probing

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Gingivitis

Description

Modified Gingival \index

Time Frame

4 weeks

Title

Plaque

Description

Rustogi Modification of the Navy Plaque Index

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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).

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Two Interdental Cleaners

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