Dental Plaque, Gingivitis
Conditions
Keywords
Tooth Whitening
Brief summary
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
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.
Interventions
OTHERToothbrushing
Mechanical plaque removal
OTHERFluoridated Dentifrice (.15% sodium monofluorophosphate)
Fluoridated dentifrice application
OTHERFluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)
Application of Tooth Whitening Agent in Dentifrice
OTHERWhitening (4.5% hydrogen peroxide)
Application of Whitening Agent
OTHEROther Fluoridated Dentifrice (.454% stannous fluoride)
Fluoridated dentifrice application
Sponsors
Pearl Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject males or females 18 to 70 years old (inclusive). 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
Potential subjects must NOT HAVE ANY of the following conditions: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tooth Whitening Shade Evaluation | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient Questionnaire | 6 months |
| Plaque Index | 6 months |
| Gingival Index | 6 months |
Countries
United States
Outcome results
None listed