A Clinical and Imaging Study to Evaluate a Novel Dentifrice (NCT02271815) | Clinical Trial Compass
CompletedNot Applicable
A Clinical and Imaging Study to Evaluate a Novel Dentifrice
United States194 participantsStarted 2014-10
Plain-language summary
There is a need for toothpastes that more effectively remove oral biofilm, inhibit biofilm re-formation and support periodontal health. This is particularly important for patients with long-term orthodontic fixtures or prosthodontic appliances, and also for debilitated, diabetic and immunocompromised patients. The objective of this study is to evaluate the effects of toothpastes on plaque presence and removal, gingival and periodontal health, dental hard tissue mineralization, erosion, abrasion, and microstructure as well as dry/sore mouth. In addition to clinical scoring and photographs, tooth and gum sensitivity, saliva volume, pH and buffering and enamel health may be evaluated using tooth samples worn on removable dental retainers. These samples will be examined outside of the mouth using advanced optical techniques such as Optical Coherence Tomography (OCT), Fluorescence, various forms of microscopy and spectroscopy.
Who can participate
Age range
18 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:
* Male or female over the age of 18
* Have a previously diagnosed condition of gingivitis and periodontitis including gingival bleeding, gingival inflammation, plaque, and for some study sections at least four sites with probing pocket depths \> 4mm.
* Not pregnant and not lactating.
Exclusion Criteria:
* Participated in other clinical study within the last 30 days.
* Plan to receive dental treatment during the study dates.
* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
* Allergies to personal care/consumer products or their ingredients.
* Less than 20 teeth (excluding third molars).
* For some studies, within six months prior to baseline, any quadrant or maintenance S/RP, and/or periodontal surgical therapy
* Diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C and other significant disease or disorder.
* Poorly controlled diabetes
* History of herpetic infection, recurrent aphthous ulcer, or other ulcerative diseases, abscesses, granulomas.
* History of or currently undergoing immunosuppression
* Taken antibiotics in the previous 3 months.
* Taking anti-inflammatory medications or Immunosuppressants.
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.