Plaque Induced GingivitisNCT05441371
Antibacterial Effect of Paradontax Toothpaste
A study testing Toothpaste; Paradontax in people with Plaque Induced Gingivitis and Plaque, Dental, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis, Plaque, Dental
- What is being tested?
- Toothpaste; Paradontax
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 21 Apr 2022to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Toothpaste; Paradontax
- Keywords
- split mouth, chemical plaque control
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste; ParadontaxOther
Comparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test; Parodontax toothpaste | Experimental | 1.st quadrant of subject Receives: Other: Toothpaste; Paradontax |
| Control; Regular toothpaste | Placebo comparator | 2.nd quadrant of subject Receives: Other: Toothpaste; Paradontax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (PI)
Amount of plaque at surfaces
Measured: 21 days
Secondary outcomes (2)
Gingival bleeding (GI)
Inflammation/bleeding on gentle probing of gingiva
Measured: 21 days
Presence of plaque at entire tooth
Amount of surface covered by plaque visualized by discolouration
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start21 Apr 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque Induced GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Split mouth
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odd Carsten Koldsland, University of Oslo
- Investigators
- Carl Hjortsjø, Ph.D, Study chair, Head of Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441371
- Sponsor's protocol ID
- REK 370116
- Status last verified
- Nov 2022
- First submitted
- 9 Jun 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37170260
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effect of Paradontax Toothpaste
- ClinicalTrials.gov ID
- NCT05441371
- Acronym / sponsor ID
- REK 370116
- Conditions
- Plaque Induced Gingivitis, Plaque, Dental
- Keywords
- split mouth, chemical plaque control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split mouth
| Arm | Type | Receives |
|---|---|---|
| Test; Parodontax toothpaste | Experimental | Other: Toothpaste; Paradontax1.st quadrant of subject |
| Control; Regular toothpaste | Placebo comparator | Other: Toothpaste; Paradontax2.nd quadrant of subject |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste; ParadontaxComparison of Paradontax toothpaste anti-plaque abality versus regular toothpaste | Other | Control; Regular toothpaste, Test; Parodontax toothpaste |
Primary outcome
Plaque Index (PI)
Time frame: 21 days
Amount of plaque at surfaces
2 secondary outcomes
Gingival bleeding (GI)
Time frame: 21 days
Presence of plaque at entire tooth
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 37170260Abrahamsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Hjortsjø, Ph.D study chair
Head of Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste; Paradontax in people with Plaque Induced Gingivitis and Plaque, Dental, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (PI) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 26 Oct 2026.