Antibacterial Effect of Paradontax Toothpaste

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.

Study Overview

• Status: Completed
• Conditions: Plaque Induced Gingivitis; Plaque, Dental
• Intervention / Treatment: Other: Toothpaste; Paradontax

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0316
    • Dental faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Parodontax toothpaste; 1.st quadrant of subject	Other: Toothpaste; Paradontax; Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste
Placebo Comparator: Control; Regular toothpaste; 2.nd quadrant of subject	Other: Toothpaste; Paradontax; Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (PI)	Amount of plaque at surfaces	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival bleeding (GI)	Inflammation/bleeding on gentle probing of gingiva	21 days
Presence of plaque at entire tooth	Amount of surface covered by plaque visualized by discolouration	21 days

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Study Chair: Carl Hjortsjø, Ph.D, Head of Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: split mouth; chemical plaque control
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque
• Other Study ID Numbers: REK 370116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No