A Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities

Completed · Not applicable

Conditions studied: Gingivitis

In brief

The purpose of this research study is to compare the interproximal plaque removal ability of Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik Waterflosser. In addition, we seek to learn more about the results of using this device on plaque accumulation and what biological processes influence the makeup of plaque and reduction of gingivitis.

Key facts

Study ID

NCT01307358

Run by

University of North Carolina, Chapel Hill

People needed

80

Starts

2011-02-01

Expected to finish

2011-04-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• are in good/excellent health
• are 18 - 70 years old
• have abstained from all oral care in the 12 hours prior to their scheduled appointment, but no more than 18 hours prior
• have abstained from consumption of apples and other sticky fruits in the 12 hours prior to their appointment
• 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 : The following are the IU test site qualifiers:
• Each IU test site shall consist of two adjacent teeth with un-restored interproximal surfaces with a closed contact. (Note: restorations are permissible if they do not interfere with plaque and GCF sampling as determined by examiner discretion)
• IU test sites of choice are as follows in the order of preference:
• Molar/premolar
• Premolar/premolar
• Molar/molar
• molar/canine
• have PPD ≤ 4mm at all four sites within each interproximal unit test site
• have ≥ 20 bleeding sites (whole mouth) as determined by the Gingival Bleeding Index
• 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 subject 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)

Where it is running

• GO Health Center, University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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