Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT02151058
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 - 65 years.
2. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
3. Able to provide written informed consent;
4. Male or non-pregnant, non-lactating female (self-reported)
5. 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
6. Medically acceptable forms of birth control that may be used by the subject and/or his/her partner
7. Able to read and understand the local language;
8. Able to follow study procedures;
9. Willing for this to be the only investigational product used during this time period; and
10. Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.
11. 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:
1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, and marijuana) opiates.
2. Females who are pregnant or breastfeeding.
3. Males with a pregnant partner or a partner who is currently trying to become pregnant.
4. Known sensitivity or history of significant adverse effects to any of the investigational products.
5. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
6. Participated in tooth stain removal trials in the least 3 months
7. Participation in any other clinical study within 30 days of Visit 1.
8. 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).
9. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02151058
Study Brief:
Protocol Section:
NCT02151058