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

This study has been completed.
Sponsor:
Collaborator:
Philips Oral Healthcare
Information provided by (Responsible Party):
Steven Offenbacher, DDS, PhD, MMSc, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01307358
First received: February 28, 2011
Last updated: November 6, 2013
Last verified: October 2013
  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 Phase
Mild Gingivitis
Device: Sonicare Interproximal (IP) Cleaning Prototype
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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 University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • residual protein concentration in posterior sites [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GBI and MGI [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 28, 2011
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014