A Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities
PAU
A Randomized Parallel Study Comparing the Interproximal Plaque and Gingivitis Effects of Three Interdental Cleaning Modalities
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedAugust 31, 2018
January 1, 2017
2 months
February 28, 2011
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
residual protein concentration in posterior sites
2 weeks
Secondary Outcomes (1)
GBI and MGI
2 weeks
Study Arms (4)
Manual Toothbrush + Sonicare Interproximal Cleaning Prototype
EXPERIMENTALManual Toothbrush + Sonicare Interproximal (IP) Cleaning Prototype
Manual Toothbrush
ACTIVE COMPARATORManual Toothbrush
Manual Toothbrush + Floss
ACTIVE COMPARATORManual Toothbrush + Floss
Manual Toothbrush + Waterpik Ultra Water Flosser
ACTIVE COMPARATORManual Toothbrush + Waterpik Ultra Water Flosser
Interventions
Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
Eligibility Criteria
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
- +2 more criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Philips Oral Healthcarecollaborator
Study Sites (1)
GO Health Center, University of North Carolina
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Offenbacher, DDS,PhD,MMS
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 2, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
August 31, 2018
Record last verified: 2017-01