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Assessing the Effects of Three Oral Care Regimens

Primary Purpose

Dental Plaque, Gingivitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Toothbrushing

Fluoridated Dentifrice (.15% sodium monofluorophosphate)

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

Whitening (4.5% hydrogen peroxide)

Other Fluoridated Dentifrice (.454% stannous fluoride)

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Tooth Whitening

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Frederick A. Curro, DMD, PhD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Whitening and Dentifrice

Whitening Dentifrice

Dentifrice

Arm Description

Outcomes

Primary Outcome Measures

Tooth Whitening Shade Evaluation

Secondary Outcome Measures

Patient Questionnaire

Plaque Index

Gingival Index

Full Information

NCT ID

NCT02940821

First Posted

October 6, 2016

Last Updated

November 13, 2017

Sponsor

Pearl Network

1. Study Identification

Unique Protocol Identification Number

NCT02940821

Brief Title

Assessing the Effects of Three Oral Care Regimens

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

May 30, 2016 (Actual)

Primary Completion Date

July 27, 2017 (Actual)

Study Completion Date

July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pearl Network

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Plaque, Gingivitis

Keywords

Tooth Whitening

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whitening and Dentifrice

Arm Type

Active Comparator

Arm Title

Whitening Dentifrice

Arm Type

Active Comparator

Arm Title

Dentifrice

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Toothbrushing

Other Intervention Name(s)

Toothbrush

Intervention Description

Mechanical plaque removal

Intervention Type

Other

Intervention Name(s)

Fluoridated Dentifrice (.15% sodium monofluorophosphate)

Intervention Description

Fluoridated dentifrice application

Intervention Type

Other

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

Application of Tooth Whitening Agent in Dentifrice

Intervention Type

Other

Intervention Name(s)

Whitening (4.5% hydrogen peroxide)

Intervention Description

Application of Whitening Agent

Intervention Type

Other

Intervention Name(s)

Other Fluoridated Dentifrice (.454% stannous fluoride)

Other Intervention Name(s)

Fluoridated dentifrice (.454% stannous fluoride)

Intervention Description

Fluoridated dentifrice application

Primary Outcome Measure Information:

Title

Tooth Whitening Shade Evaluation

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Patient Questionnaire

Time Frame

6 months

Title

Plaque Index

Time Frame

6 months

Title

Gingival Index

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick A Curro, DMD, PhD

Organizational Affiliation

Pearl Network

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ashley C Grill, MPH, RDH

Organizational Affiliation

Pearl Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

Frederick A. Curro, DMD, PhD

City

Emerson

State/Province

New Jersey

ZIP/Postal Code

07630

Country

United States

12. IPD Sharing Statement

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Assessing the Effects of Three Oral Care Regimens

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