Assessing the Effects of Three Oral Care Regimens

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Emerson, New Jersey, United States, 07630
      • Frederick A. Curro, DMD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tooth Whitening Shade Evaluation	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Plaque Index	6 months
Gingival Index	6 months
Patient Questionnaire	6 months

Collaborators and Investigators

• Sponsor: Pearl Network
• Investigators: Study Director: Frederick A Curro, DMD, PhD, Pearl Network; Principal Investigator: Ashley C Grill, MPH, RDH, Pearl Network

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2016
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): July 27, 2017

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Tooth Whitening
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Fluorides; Hydrogen Peroxide; Tin Fluorides; Fluorophosphate
• Other Study ID Numbers: PRL1517