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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
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plaque Induced Gingivitis focused on measuring split mouth, chemical plaque control

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 9, 2022
Last Updated
November 2, 2022
Sponsor
University of Oslo
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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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