Antibacterial Effect of Paradontax Toothpaste
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2022
CompletedFirst Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2022
CompletedNovember 3, 2022
November 1, 2022
3 months
June 9, 2022
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque Index (PI)
Amount of plaque at surfaces
21 days
Secondary Outcomes (2)
Gingival bleeding (GI)
21 days
Presence of plaque at entire tooth
21 days
Study Arms (2)
Test; Parodontax toothpaste
EXPERIMENTAL1.st quadrant of subject
Control; Regular toothpaste
PLACEBO COMPARATOR2.nd quadrant of subject
Interventions
Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dental faculty
Oslo, 0316, Norway
Related Publications (1)
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.
PMID: 37170260DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carl Hjortsjø, Ph.D
Head of Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 9, 2022
First Posted
July 1, 2022
Study Start
April 21, 2022
Primary Completion
July 12, 2022
Study Completion
July 12, 2022
Last Updated
November 3, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share