Antibacterial Effect of Paradontax Toothpaste

NCT ID: NCT05441371

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2022-07-12

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

Conditions

Plaque Induced Gingivitis; Plaque, Dental

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Test; Parodontax toothpaste

1.st quadrant of subject

Group Type: EXPERIMENTAL

Toothpaste; Paradontax

Intervention Type: OTHER

Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste

Control; Regular toothpaste

2.nd quadrant of subject

Group Type: PLACEBO_COMPARATOR

Toothpaste; Paradontax

Intervention Type: OTHER

Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste

Interventions

Toothpaste; Paradontax

Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Odd Carsten Koldsland

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl Hjortsjø, Ph.D

Role: STUDY_CHAIR

Head of Institute

Locations

Dental faculty

Oslo, , Norway

Countries

Norway

References

Abrahamsen S, Koldsland OC, Preus HR. The anti-plaque effect of high concentration sodium bicarbonate dentifrice on plaque formation and gingival inflammation, irrespective to individual polishing technique and plaque quality. BMC Oral Health. 2023 May 11;23(1):281. doi: 10.1186/s12903-023-03005-y.

Reference Type: DERIVED

PMID: 37170260 (View on PubMed)

Other Identifiers

REK 370116

Identifier Type: -

Identifier Source: org_study_id