Assessing the Effects of Three Oral Care Regimens

Pearl Network

Status: Completed

Conditions: Dental Plaque; Gingivitis

Treatments: Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate); Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide); Other: Toothbrushing; Other: Whitening (4.5% hydrogen peroxide); Other: Other Fluoridated Dentifrice (.454% stannous fluoride)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02940821

PRL1517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 3 patient groups

Whitening and Dentifrice

Active Comparator group

Treatment:

Other: Other Fluoridated Dentifrice (.454% stannous fluoride)

Other: Toothbrushing

Other: Whitening (4.5% hydrogen peroxide)

Whitening Dentifrice

Active Comparator group

Treatment:

Other: Toothbrushing

Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)

Dentifrice

Active Comparator group

Treatment:

Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate)

Other: Toothbrushing