Assessing the Effects of Three Oral Care Regimens

Study Overview
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Brief Summary
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Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: A randomized, person-centric, comparative effectiveness clinical research study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.

Detailed Description
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Six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized intervention groups using FDA marketed and approved products and devices. One hundred fifty (150) subjects from the patient base of 10 PEARL Network associated dental offices on the East Coast of the United States will be entered into the clinical research study. This is a post-marketing comparative effectiveness research study. Having a total of 5 visits over a six month period. Adverse events and side effects for the products used are being assessed.

Official Title
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Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening

Conditions
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Dental Plaque, Gingivitis

Intervention / Treatment
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* Other: Toothbrushing
* Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate)
* Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)
* Other: Whitening (4.5% hydrogen peroxide)
* Other: Other Fluoridated Dentifrice (.454% stannous fluoride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject males or females 18 to 70 years old (inclusive). Availability for the 6 months duration of the clinical research study Good general health Subject able and willing to follow study procedures and instructions Subject read, understood and signed an informed consent form 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 Potential subjects must NOT HAVE ANY of the following conditions: Presence of orthodontic bands Presence of partial removable dentures Tumor(s) of the soft or hard tissues of the oral cavity Restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 & #11 (upper six front teeth) Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) Five or more carious lesions requiring immediate restorative treatment Antibiotic use any time during the one month prior to entry into the study Participation in any other clinical study or test panel within the one month prior to entry into the study History of allergies to oral care/personal care consumer products or their ingredients. On any prescription medicines that might interfere with the study outcome An existing medical condition which prohibits eating or drinking for periods up to 4 hours History of alcohol or drug abuse Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whitening and Dentifrice<br> | Other: Toothbrushing<br>* Mechanical plaque removal<br>* Other names: Toothbrush;Other: Whitening (4.5% hydrogen peroxide)<br>* Application of Whitening Agent<br>Other: Other Fluoridated Dentifrice (.454% stannous fluoride)<br>* Fluoridated dentifrice application<br>* Other names: Fluoridated dentifrice (.454% stannous fluoride);|
| Active Comparator: Whitening Dentifrice<br> | Other: Toothbrushing<br>* Mechanical plaque removal<br>* Other names: Toothbrush;Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)<br>* Application of Tooth Whitening Agent in Dentifrice<br>* Other names: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushing;|
| Active Comparator: Dentifrice<br> | Other: Toothbrushing<br>* Mechanical plaque removal<br>* Other names: Toothbrush;Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate)<br>* Fluoridated dentifrice application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth Whitening Shade Evaluation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Questionnaire |  | 6 months | 
| Plaque Index |  | 6 months | 
| Gingival Index |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth Whitening