A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal

NCT02151058 | Completed Results

• 1 other identifier: CO-131219112750-CTOC
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to compare to brushing alone. 225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline 3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of use). Volunteers will maintain a diary at home to record each treatment use. Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).

Conditions

Tooth Stain

Keywords

Staining; Intensity; Area

Outcome Measures

Primary Outcomes (1)

• Lobene Stain Index Composite Score at Day 15

  Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region and 3 = covering \> 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth).

  15 Days

Secondary Outcomes (8)

• Lobene Stain Index Composite Score at Day 4

  4 Days

• Lobene Stain Index Composite Score at Day 8

  8 Days

• Lobene Stain Index Area Scores at Day 4

  4 Days

• Lobene Stain Index Area Scores at Day 8

  8 Days

• Lobene Stain Index Area Scores at Day 15

  15 Days

Study Arms (3)

Negative Control, 035000513007

OTHER

Colgate® Regular Cavity Protection

Drug: Colgate® Regular Cavity Protection

Experimental Mouth Rinse, 19545-118

EXPERIMENTAL

Drug: Experimental Mouth Rinse

Active Comparator: Mouth Rinse 037000089872

ACTIVE COMPARATOR

Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint

Other: Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint

Interventions

Colgate® Regular Cavity Protection DRUG

Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection)

Negative Control, 035000513007

Experimental Mouth Rinse DRUG

Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.

Experimental Mouth Rinse, 19545-118

Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint OTHER

Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.

Active Comparator: Mouth Rinse 037000089872

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65 years.
• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
• Able to provide written informed consent;
• Male or non-pregnant, non-lactating female (self-reported)
• Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product
• Medically acceptable forms of birth control that may be used by the subject and/or his/her partner
• Able to read and understand the local language;
• Able to follow study procedures;
• Willing for this to be the only investigational product used during this time period; and
• Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.
• Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator

You may not qualify if:

• Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, and marijuana) opiates.
• Females who are pregnant or breastfeeding.
• Males with a pregnant partner or a partner who is currently trying to become pregnant.
• Known sensitivity or history of significant adverse effects to any of the investigational products.
• Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
• Participated in tooth stain removal trials in the least 3 months
• Participation in any other clinical study within 30 days of Visit 1.
• Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

Salus Research Inc

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Michael Lynch, DMD, PhD/Study Director
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

mlynch23@its.jnj.com

908-433-6423 USA EST

Study Officials

• Jeffery Milleman Milleman, DDS, MPA

  Salus Research Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2014-10

Locations

US (1)