Clinical trial NCT02940821: Assessing the Effects of Three Oral Care Regimens
Official title: Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Gingivitis
Keywords: Tooth Whitening
Lead sponsor: Pearl Network
Sponsor class: NETWORK
First posted: 2016-10-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Tooth Whitening Shade Evaluation
timeFrame: 6 months
Secondary outcomes:
measure: Patient Questionnaire
timeFrame: 6 months
measure: Plaque Index
timeFrame: 6 months
measure: Gingival Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Emerson
country: United States
facility: Frederick A. Curro, DMD, PhD
state: New Jersey
Study officials:
affiliation: Pearl Network
name: Frederick A Curro, DMD, PhD
role: STUDY_DIRECTOR
affiliation: Pearl Network
name: Ashley C Grill, MPH, RDH
role: PRINCIPAL_INVESTIGATOR
References: