A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal (NCT02151058) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
United States227 participantsStarted 2014-06
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lobene Stain Index Composite Score at Day 15
Timeframe: 15 Days
Trial details
NCT IDNCT02151058
SponsorJohnson & Johnson Consumer and Personal Products Worldwide
. 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).