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Dental Plaque Removal Study (PAU2)

Primary Purpose

Gingivitis, Gum Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Toothbrush only
MTB + Waterpik Ultra Water Flosser 'High'
MTB + Floss (MTB+Floss)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gingivitis focused on measuring plaque removal methods, oral hygiene devices

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General and Oral Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Experimental

Arm Label

Control

Test

MTB + Waterpik Ultra Water Flosser High

Arm Description

ADA (American Dental Association) Reference Manual Toothbrush (MTB)

MTB + Floss

MTB + Waterpik Ultra Water Flosser High

Outcomes

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
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).
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
Safety endpoints based on adverse event reports and intraoral exam (soft tissue evaluation)findings.

Full Information

First Posted
March 6, 2012
Last Updated
August 28, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Philips Oral Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01559987
Brief Title
Dental Plaque Removal Study
Acronym
PAU2
Official Title
A Randomized Parallel Method Development Study Comparing Clinical to Subclinical Effects From Oral Cleaning Modalities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Philips Oral Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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. The devices used in this study are subject only to Class I (general controls) and considered exempt from the premarket notification procedures and not subject to section 510(k), 515, or 520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the definition of an Applicable Clinical Trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Gum Disease
Keywords
plaque removal methods, oral hygiene devices

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
ADA (American Dental Association) Reference Manual Toothbrush (MTB)
Arm Title
Test
Arm Type
Other
Arm Description
MTB + Floss
Arm Title
MTB + Waterpik Ultra Water Flosser High
Arm Type
Experimental
Arm Description
MTB + Waterpik Ultra Water Flosser High
Intervention Type
Other
Intervention Name(s)
Manual Toothbrush only
Intervention Description
ADA (American Dental Association) Reference Manual Toothbrush (MTB)
Intervention Type
Other
Intervention Name(s)
MTB + Waterpik Ultra Water Flosser 'High'
Intervention Description
MTB + Waterpik Ultra Water Flosser 'High'
Intervention Type
Other
Intervention Name(s)
MTB + Floss (MTB+Floss)
Intervention Description
MTB + Floss (MTB+Floss)
Primary Outcome Measure Information:
Title
residual protein concentration in posterior sites following in-clinic use of MTB (Manual Toothbrush)+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone
Description
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.
Time Frame
Baseline and Week 2
Secondary Outcome Measure Information:
Title
Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level).
Description
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.
Time Frame
Baseline and Week 2
Title
Number of Adverse Events and Intraoral Exams
Description
Safety endpoints based on adverse event reports and intraoral exam (soft tissue evaluation)findings.
Time Frame
Baseline and week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Offenbacher, DDS, PhD, MMSc
Organizational Affiliation
UNC School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
General and Oral Health Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Dental Plaque Removal Study

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