Clinical trial NCT05441371: Antibacterial Effect of Paradontax Toothpaste
Official title: Antibacterial Effect of Paradontax Toothpaste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Induced Gingivitis
Plaque, Dental
Keywords: split mouth
chemical plaque control
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split mouth
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

Healthy people of both sexes

* age 18-35 years
* Have at least three of the following teeth: 16, 15, 14, 13, 23, 24, 25, 26 with healthy gingiva.
* Non-smokers
* Has signed an informed consent document

Exclusion Criteria:

Pregnancy and breast-feeding.

* Any chronic disease Clinical or other symptoms of oral disease
* Any prescribed or over-the-counter systemic or topical medication with the exception of oral contraceptives used within one week prior to the start of the study.
* Haematological and clinical / chemical parameters considered unacceptable by the project manager.
* Use of antibiotics within the last three months before the start of the study.
* Alcohol or drug / drug abuse
* Participation in other clinical studies in the last 4 weeks before the start of the study.

Primary outcomes:
measure: Plaque Index (PI)
timeFrame: 21 days
Secondary outcomes:
measure: Gingival bleeding (GI)
timeFrame: 21 days
measure: Presence of plaque at entire tooth
timeFrame: 21 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dental faculty
Study officials:
affiliation: Head of Institute
name: Carl Hjortsjø, Ph.D
role: STUDY_CHAIR
References: