Clinical Study to Evaluate the Tooth Whitening Efficacy (NCT06957249) | Clinical Trial Compass
CompletedPhase 3
Clinical Study to Evaluate the Tooth Whitening Efficacy
United States80 participantsStarted 2025-04-25
Plain-language summary
Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period.
Who can participate
Age range
18 Years – 70 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:
* Signed Informed Consent Form;
* Male and female subjects 18-70 years old, inclusive;
* Good general health and good oral health based on the opinion of the study investigator;
* All maxillary natural permanent anterior teeth (6-11) must be present;
* Availability for the duration of the study;
* Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker.
Exclusion Criteria:
* Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital;
* Obvious signs of periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study;
* Five or more carious lesions requiring immediate care;
* Concurrent participation in another clinical study;
* Self-reported pregnant and/or lactating women;
* History of allergies or sensitivity to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
* Restorations on the teeth to be scored which may interfere with scoring procedures;
* Have used a professional whitening product within one (1) year and/or had a dental prophylaxis (professional dental cleaning) within thirty (30) days prior to the start of the study
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.
1This was a Phase 3 trial on tooth whitening that has already been completed — can you tell me if the results have been published, and what they showed about how well the whitening treatment actually worked?
2Since this study measured tooth color as its primary outcome, what method did they use to measure color change, and would that level of whitening be considered clinically meaningful for someone in my situation?
3Are there any dental or oral health conditions I have — like sensitive teeth, existing restorations, or enamel issues — that might affect whether the whitening approach studied in this trial would be safe or appropriate for me?
4Given that this trial is already completed, are there currently approved whitening products or in-office treatments that use the same method, so I could potentially access it now without enrolling in a study?
5How does the whitening approach studied in this trial compare to what you would normally recommend for me, and is there any reason to wait for these published results before moving forward with treatment?
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.