Trial of Toothpaste to Reduce Plaque and Inflammation
|Plaque Inflammation||Other: Plaque identifying toothpaste Other: Non-plaque identifying toothpaste|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation|
- Reduction in oral plaque [ Time Frame: 30 days ]mean plaque score
- Inflammation [ Time Frame: 30 day ]hs-CRP serum level
|Study Start Date:||August 2015|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Plaque identifying toothpaste
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Other: Plaque identifying toothpaste
Plaque identifying toothpaste with targetol
Active Comparator: Non-plaque identifying toothpaste
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Other: Non-plaque identifying toothpaste
Non-plaque identifying toothpaste without targetol
The protocol was approved by the Institutional Review Board of the University of Illinois and the trial was posted on ClinicalTrials.gov. We screened all potentially eligible subjects from the Medical District of the University of Illinois which includes the Colleges of Dentistry, Medicine, Public Health and Pharmacy.
All willing and eligible subjects signed informed consent forms and were instructed to refrain from brushing or flossing teeth, using any oral hygiene aids (such as mouthwash or chewing gum) the evening prior to and the morning of the data collection appointment. All subjects were be asked to complete the following procedures:
- Rinse for 10 seconds with 25 mL of phosphate buffer
- Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer
- Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer
- Be positioned on a tripod chin rest 15 inches in front of the camera, retraction placed and intraoral images captured under UV LED light imaging.
- Provide a blood sample for hs-CRP.
- Use a 30 day supply of their assigned toothpaste and were instructed to follow the same brushing protocol for the entire month as well as a brushing diary to assist in recording daily participation.
The identical procedures were repeated at the 30 day follow up visit.. In addition, the Plaque HD group was instructed to brush in front of a mirror for 1 minute and to concentrate on removing all visible dye. The placebo group was asked to brush their teeth for 1 minute in front of a mirror, using the provided manual toothbrush.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02666508
|Contact: Kimberly Fasula, MSfirstname.lastname@example.org|
|United States, Illinois|
|UIC Clinical Research Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Maryann Holtcamp, RN, APN 312-996-2937 email@example.com|
|Principal Investigator: Kimberly Fasula, MS|
|Principal Investigator:||Kimberly Fasula, MS||University of Illinois at Chicago|