Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
1 other identifier
interventional
170
1 country
1
Brief Summary
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 1, 2010
CompletedResults Posted
Study results publicly available
September 19, 2012
CompletedSeptember 19, 2012
August 1, 2012
2 months
May 5, 2010
May 31, 2012
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Residual Protein Concentration
Residual protein concentration of interproximal plaque samples
14 days
Secondary Outcomes (5)
Residual Protein Concentration
28 days
Modified Gingival Index
14 days
Modified Gingival Index
28 days
Gingival Bleeding Index
14 days
Gingival Bleeding Index
28 days
Study Arms (4)
Manual Toothbrush 1
ACTIVE COMPARATORManual Toothbrush used for 1 minute twice a day
Manual Toothbrush 2
ACTIVE COMPARATORManual Toothbrush used for 2 minutes twice a day
Manual Toothbrush + Interproximal Cleaning 1
EXPERIMENTALManual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
Manual Toothbrush + Interproximal Cleaning 2
EXPERIMENTALManual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
Interventions
A standard size manual toothbrush to clean visible tooth surfaces
An electronic device that combines water and air to clean between the teeth
Eligibility Criteria
You may qualify if:
- are in good/excellent health;
- are 18 - 70 years old;
- have a minimum of 20 natural teeth (excluding 3rd molars);
- have sufficient test sites;
- have ≥ 20 bleeding sites;
- are willing to participate and available for participation.
You may not qualify if:
- have systemic diseases such as Down's syndrome, or known AIDS/HIV;
- have insulin dependant Diabetes;
- are pregnant or nursing by subject report;
- have a cardiac pacemaker
- are undergoing or require extensive dental or orthodontic treatment;
- require antibiotic treatment for dental appointments;
- have heavy deposits of calculus;
- have severe gingivitis or periodontitis;
- 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;
- have a professional prophylaxis within 4 weeks of study;
- participation in a prior study ≤ 20 days;
- employed by a oral healthcare products company or research institution.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Park Research Center
Fort Wayne, Indiana, 46825, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Philips Healthcare, Office of Medical and Health Affairs
Study Officials
- STUDY DIRECTOR
Wendy Jenkins
POHC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
December 1, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
September 19, 2012
Results First Posted
September 19, 2012
Record last verified: 2012-08