Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05441371 |
Other study ID # |
REK 370116 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 21, 2022 |
Est. completion date |
July 12, 2022 |
Study information
Verified date |
November 2022 |
Source |
University of Oslo |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to test the antibacterial effect of Parodontax toothpaste on
plaque formation, and thus gingivitis compared to placebo toothpaste.
Each subject will be given 2 plastic splints that are individually adapted to their quadrant
1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while
in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses
daily. Each person's set of teeth is otherwise professionally cleaned.
Description:
Each subject will be given 2 plastic splints that are individually adapted to their quadrant
1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while
in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses
daily. Each person's teeth is otherwise professionally cleaned.
Home procedure: The subject first rinses the mouth with water for 30 sec. Then both splints
are placed on the teeth in the 1st quadrant and 2nd quadrant, respectively, and the rest
(lower jaw) is brushed with the subject's regular toothpaste. The brace should be on for 1
min while cleaning the teeth in the lower jaw as usual, with its usual commercial toothpaste.
After 1 minute, rinse your mouth with water for 30 seconds. Then the splints are removed and
the mouth is immediately rinsed with water for another 30 sec. The procedure is repeated
twice a day (morning and evening) for 3 weeks (21 days). In this way, the test person becomes
his own control (1st quadrant versus 2nd quadrant), and the individual plaque quality is
subordinate to what it would not otherwise be in a 2-group study. Furthermore, individual
brushing technique will not be an issue, as we only test the antibacterial effect of the
toothpaste in the splint quadrants. It is the antibacterial effect of Parodontax we test, not
affected by brushing technique.
Health information that includes age, medication use, allergies, diseases, and tobacco use.
Following the test period, registration of plaque (Silness&Loe/Quigley&Hines) and gingival
bleeding (Loe&Silness) will be registered