Status:
COMPLETED
A Clinical and Imaging Study to Evaluate a Novel Dentifrice
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Livionex Inc.
Conditions:
Gingivitis
Periodontitis
Eligibility:
All Genders
18+ years
Brief 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 ortho...
Detailed Description
The objective of this study is to evaluate the in vivo effects of toothpastes and dental gels on gingival and periodontal health, enamel demineralization, remineralization and microstructure . The pur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT02271815
Start Date
October 1 2014
End Date
June 1 2021
Last Update
September 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beckman Laser Institute, University of california, Irvine
Irvine, California, United States, 92612