Dental Plaque Removal Study

NCT01559987 | Completed

• 1 other identifier: MAH-11-0059
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Gum Disease

Keywords

plaque removal methods; oral hygiene devices

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 2

Secondary Outcomes (2)

• Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level).

  Baseline and Week 2

• Number of Adverse Events and Intraoral Exams

  Baseline and week 2

Study Arms (3)

Control

OTHER

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

Other: Manual Toothbrush only

Test

OTHER

MTB + Floss

Other: MTB + Floss (MTB+Floss)

MTB + Waterpik Ultra Water Flosser High

EXPERIMENTAL

MTB + Waterpik Ultra Water Flosser High

Other: MTB + Waterpik Ultra Water Flosser 'High'

Interventions

Manual Toothbrush only OTHER

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

Control

MTB + Waterpik Ultra Water Flosser 'High' OTHER

MTB + Waterpik Ultra Water Flosser 'High'

MTB + Waterpik Ultra Water Flosser High

MTB + Floss (MTB+Floss) OTHER

MTB + Floss (MTB+Floss)

Test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Philips Oral Healthcare: collaborator

Study Sites (1)

General and Oral Health Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Gingivitis; Gingival Diseases

Condition Hierarchy (Ancestors)

Infections; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Steven Offenbacher, DDS, PhD, MMSc

  UNC School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 31, 2018

Record last verified: 2017-01

Locations

US (1)