- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250769
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
August 21, 2012 updated by: Philips Oral Healthcare
Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46825
- University Park Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Manual Toothbrush 1
Manual Toothbrush used for 1 minute twice a day
|
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
|
Active Comparator: Manual Toothbrush 2
Manual Toothbrush used for 2 minutes twice a day
|
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
|
Experimental: Manual Toothbrush + Interproximal Cleaning 1
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
|
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
An electronic device that combines water and air to clean between the teeth
Other Names:
|
Experimental: Manual Toothbrush + Interproximal Cleaning 2
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
|
A standard size manual toothbrush to clean visible tooth surfaces
Other Names:
An electronic device that combines water and air to clean between the teeth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual Protein Concentration
Time Frame: 14 days
|
Residual protein concentration of interproximal plaque samples
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual Protein Concentration
Time Frame: 28 days
|
Residual protein concentration of interproximal plaque samples
|
28 days
|
Modified Gingival Index
Time Frame: 14 days
|
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
|
14 days
|
Modified Gingival Index
Time Frame: 28 days
|
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
|
28 days
|
Gingival Bleeding Index
Time Frame: 14 days
|
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
|
14 days
|
Gingival Bleeding Index
Time Frame: 28 days
|
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Wendy Jenkins, POHC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 5, 2010
First Submitted That Met QC Criteria
November 29, 2010
First Posted (Estimate)
December 1, 2010
Study Record Updates
Last Update Posted (Estimate)
September 19, 2012
Last Update Submitted That Met QC Criteria
August 21, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRC-0703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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