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Dental Plaque Removal Study (PAU2)

This study has been completed.
Sponsor:
Collaborator:
Philips Oral Healthcare
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01559987
First received: March 6, 2012
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this research study is to investigate water flow in dental devices and to understand the function of water flow behind oral hygiene improvements. Understanding this mechanism may help with the design of future products.


Condition Intervention
Gingivitis
Gum Disease
 Device: Manual Toothbrush only
Device: MTB + Waterpik Ultra Water Flosser 'High'
Device: MTB + Floss (MTB+Floss)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Basic Science
Official Title: A Randomized Parallel Method Development Study Comparing Clinical to Subclinical Effects From Oral Cleaning Modalities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • residual protein concentration in posterior sites following in-clinic use of MTB (Manual Toothbrush)+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    The primary endpoint of this study is the residual protein concentration in posterior sites following in-clinic use of MTB+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone.


Secondary Outcome Measures:
  • Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level). [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    To evaluate the impact of a fluid cleaning principle (MTB+Waterpik Waterflosser) relative to MTB+Floss and MTB alone on clinical outcomes: Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level.

  • Number of Adverse Events and Intraoral Exams [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: Yes ]
    Safety endpoints based on adverse event reports and intraoral exam (soft tissue evaluation)findings.


Enrollment: 270
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
ADA (American Dental Association) Reference Manual Toothbrush (MTB)
 Device: Manual Toothbrush only
ADA (American Dental Association) Reference Manual Toothbrush (MTB)
Test
MTB + Floss
 Device: MTB + Floss (MTB+Floss)
MTB + Floss (MTB+Floss)
Experimental: MTB + Waterpik Ultra Water Flosser High
MTB + Waterpik Ultra Water Flosser High
 Device: MTB + Waterpik Ultra Water Flosser 'High'
MTB + Waterpik Ultra Water Flosser 'High'

Detailed Description:

The overall clinical response (plaque, gingivitis, bleeding) in participants with varying stages of gingival health as well as the causative or indicative hallmarks of selected biological responses underpinning the overt clinical manifestations described above will be evaluated. The chief biological response that will be investigated is how a reduction in the concentration of bacterial lipopolysaccharide endotoxins (LPS) in interproximal plaque may influence improvements in the clinical response (e.g., through mitigation of bleeding) when compared to a change in the plaque biomass within which a large component of the endotoxins reside. The hypothesis is that improvements in clinical bleeding may result more from the removal or reduction of toxic bacterial products that serve as the direct impetus of the inflammatory response rather than from sheer bulk removal of interproximal plaque. From a methods development perspective, this study will also assess the feasibility of measuring endotoxin load from clinical samples. Ultimately it is anticipated that a comprehensive evaluation of clinical benefits conferred by continuous fluid streaming will emerge upon analysis of the relationships between clinical and biological data sets, particularly where causal relationships may exist between both parameters.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • are in good general health
  • are 18 - 75 years old;
  • have and will abstain from all oral care in the 12 hours prior to each scheduled appointment, but no more than 18 hours prior.
  • have and will abstain from consumption of apples and other sticky fruits in the 12 hours prior to each appointment.
  • agree to abstain from eating, drinking, chewing gum, and the use of breath mints, etc in the one hour preceding saliva collection at Visits 2 and 3
  • 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 (see Section 5.1.1, Interproximal Unit (IU)Test Site Selection, for definition);
  • present with one of the following three categories:
  • BGI-gingivitis: all PD<3mm, BOP>10%;
  • BGI-periodontitis (P2): 1+ site with PD>3mm, BOP>10% but <50%
  • BGI-periodontitis (P3): 1+ site with PD>3mm, BOP>50%
  • 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 participant 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)
  • have heavy deposits of calculus, either supragingival and/or subgingival;
  • have extensive crown or bridge work and/or rampant decay;
  • currently use bleaching trays;
  • have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
  • have a professional prophylaxis within 4 weeks of study;
  • have participated in a prior study ≤ 20 days;
  • participated in Philips study DRC-0742;
  • are employed by an oral healthcare products company or dental research institution (i.e., dental school: administrative staff, assistants, hygienists, and research students).
  • are a dentist, dental student or dental professional
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559987

Locations
United States, North Carolina
General and Oral Health Center
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, MMSc UNC School of Dentistry
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01559987     History of Changes
Other Study ID Numbers: MAH-11-0059
Study First Received: March 6, 2012
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
plaque removal methods
oral hygiene devices

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

ClinicalTrials.gov processed this record on May 21, 2013