Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System (NCT06613347) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System
United States93 participantsStarted 2024-10-07
Plain-language summary
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste
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:
* permanent natural teeth (6-11) (22-27)
* composite lobene =\>1
* Signed Informed Consent Form
* Male and female subjects aged 18-70 years, inclusive
* Good general health and good oral health based on the opinion of the study investigator
* All maxillary anterior teeth (teeth #6 through #11) must be present;\& mandibular anterior ( Teeth #22 through 27) must be present
* Availability for the duration of the study
* Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker
* A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index
* Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)
Exclusion Criteria:
* allergies
* Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
* Restorations on the tooth to be scored which may interfere with scoring procedures
* 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 to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients
* Have dentinal sensitivity
* Taking medication within a year which could alters natural tooth color or appearance,
* Have used Professiona…
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.