Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2016-05-30
2017-07-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Whitening and Dentifrice
Toothbrushing
Mechanical plaque removal
Whitening (4.5% hydrogen peroxide)
Application of Whitening Agent
Other Fluoridated Dentifrice (.454% stannous fluoride)
Fluoridated dentifrice application
Whitening Dentifrice
Toothbrushing
Mechanical plaque removal
Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)
Application of Tooth Whitening Agent in Dentifrice
Dentifrice
Toothbrushing
Mechanical plaque removal
Fluoridated Dentifrice (.15% sodium monofluorophosphate)
Fluoridated dentifrice application
Interventions
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Toothbrushing
Mechanical plaque removal
Fluoridated Dentifrice (.15% sodium monofluorophosphate)
Fluoridated dentifrice application
Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)
Application of Tooth Whitening Agent in Dentifrice
Whitening (4.5% hydrogen peroxide)
Application of Whitening Agent
Other Fluoridated Dentifrice (.454% stannous fluoride)
Fluoridated dentifrice application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Availability for the 6 months duration of the clinical research study
3. Good general health
4. Subject able and willing to follow study procedures and instructions
5. Subject read, understood and signed an informed consent form
6. Subject present with at least 20 natural teeth in the functional dentition (excluding third molars), including the following natural (uncrowned) teeth for shading: #6, #7, #8, #9, #10, #11
Exclusion Criteria
1. Presence of orthodontic bands
2. Presence of partial removable dentures
3. Tumor(s) of the soft or hard tissues of the oral cavity
4. Restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 \& #11 (upper six front teeth)
5. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
6. Five or more carious lesions requiring immediate restorative treatment
7. Antibiotic use any time during the one month prior to entry into the study
8. Participation in any other clinical study or test panel within the one month prior to entry into the study
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome
11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours
12. History of alcohol or drug abuse
13. Pregnant or lactating
18 Years
70 Years
ALL
Yes
Sponsors
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Pearl Network
NETWORK
Responsible Party
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Principal Investigators
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Frederick A Curro, DMD, PhD
Role: STUDY_DIRECTOR
Pearl Network
Ashley C Grill, MPH, RDH
Role: PRINCIPAL_INVESTIGATOR
Pearl Network
Locations
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Frederick A. Curro, DMD, PhD
Emerson, New Jersey, United States
Countries
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Other Identifiers
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PRL1517
Identifier Type: -
Identifier Source: org_study_id