Assessing the Effects of Three Oral Care Regimens

Not Applicable

Completed

• Conditions: Dental Plaque; Gingivitis
• Interventions: Other: Toothbrushing; Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate); Other: Whitening (4.5% hydrogen peroxide); Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide); Other: Other Fluoridated Dentifrice (.454% stannous fluoride)

• Registration Number: NCT02940821
• Lead Sponsor: Pearl Network

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.

Study Timeline

• Study Start: 2016-05-30
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dentifrice	Fluoridated Dentifrice (.15% sodium monofluorophosphate)	-
Whitening and Dentifrice	Whitening (4.5% hydrogen peroxide)	-
Whitening Dentifrice	Toothbrushing	-
Whitening and Dentifrice	Other Fluoridated Dentifrice (.454% stannous fluoride)	-
Whitening and Dentifrice	Toothbrushing	-
Whitening Dentifrice	Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)	-
Dentifrice	Toothbrushing	-

Primary Outcome Measures

Name	Time	Method
Tooth Whitening Shade Evaluation	6 months

Secondary Outcome Measures

Name	Time	Method
Patient Questionnaire	6 months
Plaque Index	6 months
Gingival Index	6 months

Trial Locations

Locations (1)

Frederick A. Curro, DMD, PhD; 🇺🇸 Emerson, New Jersey, United States