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A Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities (PAU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307358
First Posted: March 2, 2011
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Philips Oral Healthcare
Information provided by (Responsible Party):
Steven Offenbacher, DDS, PhD, MMSc, University of North Carolina, Chapel Hill
  Purpose
The purpose of this research study is to compare the interproximal plaque removal ability of Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik Waterflosser. In addition, we seek to learn more about the results of using this device on plaque accumulation and what biological processes influence the makeup of plaque and reduction of gingivitis.

Condition Intervention
Gingivitis Device: Sonicare Interproximal (IP) Cleaning Prototype

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Parallel Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities

Further study details as provided by Steven Offenbacher, DDS, PhD, MMSc, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • residual protein concentration in posterior sites [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • GBI and MGI [ Time Frame: 2 weeks ]

    GBI and MGI following single use treatment with either MTB, MTB + IP cleaning prototype, MTB + Waterpik Waterflosser or MTB + floss.

    Comparisons of the concentration levels of 272 different pathogens between treatment groups Biomarker profiles following the different treatment modalities Safety endpoints based on adverse events and intraoral exam (soft tissue evaluation).

    IP cleaning satisfaction questionnaire following treatment with either MTB, MTB + IP cleaning prototype, MTB + Waterpik Waterflosser or MTB + floss.



Enrollment: 80
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Toothbrush + Sonicare Interproximal Cleaning Prototype
Manual Toothbrush + Sonicare Interproximal (IP) Cleaning Prototype
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
Active Comparator: Manual Toothbrush
Manual Toothbrush
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
Active Comparator: Manual Toothbrush + Floss
Manual Toothbrush + Floss
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
Active Comparator: Manual Toothbrush + Waterpik Ultra Water Flosser
Manual Toothbrush + Waterpik Ultra Water Flosser
Device: Sonicare Interproximal (IP) Cleaning Prototype
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • are in good/excellent health
  • are 18 - 70 years old
  • have abstained from all oral care in the 12 hours prior to their scheduled appointment, but no more than 18 hours prior
  • have abstained from consumption of apples and other sticky fruits in the 12 hours prior to their appointment
  • have a minimum of 20 natural teeth (excluding 3rd molars)
  • have 2 qualifying Interproximal Unit test sites in each posterior quadrant from 3 approximating teeth : The following are the IU test site qualifiers:
  • Each IU test site shall consist of two adjacent teeth with un-restored interproximal surfaces with a closed contact. (Note: restorations are permissible if they do not interfere with plaque and GCF sampling as determined by examiner discretion)
  • IU test sites of choice are as follows in the order of preference:
  • Molar/premolar
  • Premolar/premolar
  • Molar/molar
  • molar/canine
  • have PPD ≤ 4mm at all four sites within each interproximal unit test site
  • have ≥ 20 bleeding sites (whole mouth) as determined by the Gingival Bleeding Index
  • have provided written informed consent and are willing to participate and be available at all times required for participation
  • are willing and able to fully understand and comply with the written and verbal study instructions provided in English
  • agree to return all study materials at the final visit

Exclusion Criteria:

  • have systemic diseases, Down's syndrome, or known AIDS/HIV;
  • Have Diabetes
  • are a smoker
  • are pregnant or nursing by subject report;
  • have a cardiac pacemaker or AICD
  • are undergoing or require extensive dental or orthodontic treatment;
  • have had oral or gum surgery in the previous 2 months;
  • require antibiotic treatment for dental appointments;
  • have used antibiotics within 4 weeks of enrollment
  • are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307358


Locations
United States, North Carolina
GO Health Center, University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Philips Oral Healthcare
Investigators
Principal Investigator: Steven Offenbacher, DDS,PhD,MMS University of North Carolina, Chapel Hill
  More Information

Responsible Party: Steven Offenbacher, DDS, PhD, MMSc, Department Chair, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01307358     History of Changes
Other Study ID Numbers: DRC-0742
First Submitted: February 28, 2011
First Posted: March 2, 2011
Last Update Posted: January 30, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases