Dental Plaque Removal Study

Completed · Not applicable

Conditions studied: Gingivitis, Gum Disease

In brief

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.

Key facts

Study ID

NCT01559987

Run by

University of North Carolina, Chapel Hill

People needed

270

Starts

2012-02-01

Expected to finish

2012-05-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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;
• 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

Where it is running

• General and Oral Health Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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