Assessing the Effects of Three Oral Care Regimens

Not Applicable

Completed

• Conditions: Dental Plaque; Gingivitis

• 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

Primary Outcome Measures

Name	Time	Method
Tooth Whitening Shade Evaluation	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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