Assessing the Effects of Three Oral Care Regimens

Sponsor

Pearl Network (Other)

Overall Status

Completed

CT.gov ID

NCT02940821

Collaborator

(none)

142

Enrollment

Location

Arms

13.9

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque Gingivitis	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)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 30, 2016

Actual Primary Completion Date :

Jul 27, 2017

Actual Study Completion Date :

Jul 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Whitening and Dentifrice	Other: Toothbrushing Mechanical plaque removal Other Names: Toothbrush Other: Whitening (4.5% hydrogen peroxide) Application of Whitening Agent Other: Other Fluoridated Dentifrice (.454% stannous fluoride) Fluoridated dentifrice application Other Names: Fluoridated dentifrice (.454% stannous fluoride)
Active Comparator: Whitening Dentifrice	Other: Toothbrushing Mechanical plaque removal Other Names: Toothbrush Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) Application of Tooth Whitening Agent in Dentifrice Other Names: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushing
Active Comparator: Dentifrice	Other: Toothbrushing Mechanical plaque removal Other Names: Toothbrush Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate) Fluoridated dentifrice application

Arm

Intervention/Treatment

Active Comparator: Whitening and Dentifrice

Other: Toothbrushing

Mechanical plaque removal

Other Names:

Toothbrush

Other: Whitening (4.5% hydrogen peroxide)

Application of Whitening Agent

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

Fluoridated dentifrice application

Other Names:

Fluoridated dentifrice (.454% stannous fluoride)

Active Comparator: Whitening Dentifrice

Other: Toothbrushing

Mechanical plaque removal

Other Names:

Toothbrush

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

Application of Tooth Whitening Agent in Dentifrice

Other Names:

Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushing

Active Comparator: Dentifrice

Other: Toothbrushing

Mechanical plaque removal

Other Names:

Toothbrush

Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate)

Fluoridated dentifrice application

Outcome Measures

Primary Outcome Measures

Tooth Whitening Shade Evaluation [6 months]

Secondary Outcome Measures

Patient Questionnaire [6 months]
Plaque Index [6 months]
Gingival Index [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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