Research - Clinical Studies
Clinical Study Title
A Randomized Parallel Method Development Study Comparing Clinical to Subclinical Effects from Oral Cleaning Modalities
****** Not currently enrolling new participants in this Clinical Study. ******
Description/Purpose of the Study
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. Understanding the mechanism by which health benefits are observed is essential to define and optimize the elements of technology design in future products.
|IRB Study #:||11-2449|
|Principal Investigator:||Steven Offenbacher|
|UNC Department:||Dental Research/GO Health Center|
You may be eligible to participate if you:
Are in good general health.
Are 18 -75 years old.
Are willing to abstain from all oral care in the 12 hours prior to your scheduled appointment, but no more than 18 hours prior.
Are willing to abstain from eating and drinking any fluids 1 hour prior to your scheduled appointment.
Are willing to abstain from consumption of applies and other sticky fruits in the 12 hours prior to your appointment.
Have a minimum of 20 natural teeth (not including 3rd molars).
Have 3 back teeth next to each other in each section of the mouth.
Have periodontal disease or gingivitis (determined upon examination).
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 should not be in this study if you:
Have systemic diseases such as Down's syndrome, or known AIDS/HIV.
Have had oral or gum surgery in the previous 2 months.
Have used antibiotics within 4 weeks of first study visit.
Are currently using prescription-dose or repeat dose (more than 2 days) anti-inflammatory medications or anticoagulants (including aspirin).
Are a smoker.
Are pregnant or nursing.
Have a cardiac pacemaker or implanted defibrillator.
Are undergoing or require extensive dental or orthodontic treatment.
Require antibiotic treatment for dental appointments.
Have heavy tartar, either above or below the gums.
Have extensive crown or bridge work and/or decay.
Currently use bleaching trays.
Have any piercing on lips or in mouth with ornament or accessory.
Have a professional cleaning within 4 weeks of the study.
Have participated in a study 20 days or less prior to this study.
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.
Have participated in study DRC-0742 (floss study performed at GO Health).