N/A
N=227
A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
Tooth Stain
Bottom Line
View on ClinicalTrials.gov: NCT02151058 ↗Enrolled (actual)
227
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Lobene Stain Index Composite Score at Day 15 — 2.568; 1.909; 1.575 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Colgate® Regular Cavity Protection (Drug); Experimental Mouth Rinse (Drug); Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lobene Stain Index Composite Score at Day 15 |
2.568; 1.909; 1.575 | <0.001 sig |
| SECONDARY Lobene Stain Index Composite Score at Day 4 |
2.527; 2.242; 2.200 | <0.001 sig |
| SECONDARY Lobene Stain Index Composite Score at Day 8 |
2.536; 2.023; 1.852 | <0.001 sig |
| SECONDARY Lobene Stain Index Area Scores at Day 4 |
1.621; 1.538; 1.502 | 0.026 sig |
| SECONDARY Lobene Stain Index Area Scores at Day 8 |
1.615; 1.439; 1.265 | 0.002 sig |
| SECONDARY Lobene Stain Index Area Scores at Day 15 |
1.629; 1.382; 1.131 | <0.001 sig |
| SECONDARY Lobene Stain Index Intensity Scores at Day 4 |
1.651; 1.527; 1.483 | 0.001 sig |
| SECONDARY Lobene Stain Index Intensity Scores at Day 8 |
1.668; 1.438; 1.355 | <0.001 sig |
| SECONDARY Lobene Stain Index Intensity Scores at Day 15 |
1.671; 1.396; 1.206 | <0.001 sig |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02151058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.