Antibacterial Effect of Paradontax Toothpaste

Plaque, Dental Clinical Trial

Official title:

Antibacterial Effect of Paradontax Toothpaste

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05441371
• Other study ID #: REK 370116
• Status: Completed
• Phase: N/A
• 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
• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Plaque Induced Gingivitis
• Plaque, Dental

Intervention

Other:
• Toothpaste; Paradontax
Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste

Locations

Country	Name	City	State
Norway	Dental faculty	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index (PI)	Amount of plaque at surfaces	21 days
Secondary	Gingival bleeding (GI)	Inflammation/bleeding on gentle probing of gingiva	21 days
Secondary	Presence of plaque at entire tooth	Amount of surface covered by plaque visualized by discolouration	21 days