Comparison of Two Interdental Cleaners

February 7, 2017 updated by: All Sum Research Center Ltd.
Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention A
water flosser
Device: water flosser
Powered
Active Comparator: Intervention B
air floss
Device: air floss
Powered

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All Sum Research Center Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 19, 2016

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-WP-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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