Assessing the Effects of Three Oral Care Regimens

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940821
• Other study ID #: PRL1517
• Status: Completed
• Phase: N/A
• First received: October 6, 2016
• Last updated: November 13, 2017
• Start date: May 30, 2016
• Est. completion date: July 27, 2017

Study information

• Verified date: November 2017
• Source: Pearl Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

Intervention

Other:
• Toothbrushing
Mechanical plaque removal
• Fluoridated Dentifrice (.15% sodium monofluorophosphate)
Fluoridated dentifrice application
• Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)
Application of Tooth Whitening Agent in Dentifrice
• Whitening (4.5% hydrogen peroxide)
Application of Whitening Agent
• Other Fluoridated Dentifrice (.454% stannous fluoride)
Fluoridated dentifrice application

Locations

Country	Name	City	State
United States	Frederick A. Curro, DMD, PhD	Emerson	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth Whitening Shade Evaluation		6 months
Secondary	Patient Questionnaire		6 months
Secondary	Plaque Index		6 months
Secondary	Gingival Index		6 months