Antibacterial Effect of Paradontax Toothpaste
Primary Purpose
Plaque Induced Gingivitis, Plaque, Dental
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Toothpaste; Paradontax
Sponsored by
About this trial
This is an interventional prevention trial for Plaque Induced Gingivitis focused on measuring split mouth, chemical plaque control
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.
Sites / Locations
- Dental faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test; Parodontax toothpaste
Control; Regular toothpaste
Arm Description
1.st quadrant of subject
2.nd quadrant of subject
Outcomes
Primary Outcome Measures
Plaque Index (PI)
Amount of plaque at surfaces
Secondary Outcome Measures
Gingival bleeding (GI)
Inflammation/bleeding on gentle probing of gingiva
Presence of plaque at entire tooth
Amount of surface covered by plaque visualized by discolouration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05441371
Brief Title
Antibacterial Effect of Paradontax Toothpaste
Official Title
Antibacterial Effect of Paradontax Toothpaste
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Induced Gingivitis, Plaque, Dental
Keywords
split mouth, chemical plaque control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split mouth
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test; Parodontax toothpaste
Arm Type
Experimental
Arm Description
1.st quadrant of subject
Arm Title
Control; Regular toothpaste
Arm Type
Placebo Comparator
Arm Description
2.nd quadrant of subject
Intervention Type
Other
Intervention Name(s)
Toothpaste; Paradontax
Intervention Description
Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste
Primary Outcome Measure Information:
Title
Plaque Index (PI)
Description
Amount of plaque at surfaces
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Gingival bleeding (GI)
Description
Inflammation/bleeding on gentle probing of gingiva
Time Frame
21 days
Title
Presence of plaque at entire tooth
Description
Amount of surface covered by plaque visualized by discolouration
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Hjortsjø, Ph.D
Organizational Affiliation
Head of Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Dental faculty
City
Oslo
ZIP/Postal Code
0316
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Antibacterial Effect of Paradontax Toothpaste
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