Antibacterial Effect of Paradontax Toothpaste

Antibacterial Effect of Paradontax Toothpaste

Sponsors

Lead Sponsor: University of Oslo

Source University of Oslo
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

Overall Status Recruiting
Start Date 2022-04-21
Completion Date 2022-07-12
Primary Completion Date 2022-07-12
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Plaque Index (PI) 21 days
Secondary Outcome
Measure Time Frame
Gingival bleeding (GI) 21 days
Presence of plaque at entire tooth 21 days
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: Toothpaste; Paradontax

Description: Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

35 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Carl Hjortsjø, Ph.D Study Chair Head of Institute
Overall Contact

Last Name: Odd Carsten Koldsland, Ph:D

Phone: +47 93098618

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Dental faculty Odd Carsten Koldsland, Ph.D +47 93098618 [email protected]
Location Countries

Norway

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Oslo

Investigator Full Name: Odd Carsten Koldsland

Investigator Title: Associate professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Test; Parodontax toothpaste

Type: Experimental

Description: 1.st quadrant of subject

Label: Control; Regular toothpaste

Type: Placebo Comparator

Description: 2.nd quadrant of subject

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Intervention Model Description: Split mouth

Primary Purpose: Prevention

Masking: None (Open Label)

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