GingivitisPhase 4NCT01317446
Effect of Mouthrinsing on Inflammation of the Gums.
A Phase 4 study testing amine fluoride/stannous fluoride in people with Gingivitis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- amine fluoride/stannous fluoride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Jan 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male and female adults aged ≥18 years.
- Participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites > 3.5 mm and < 5 mm).
- Participants must have read, understood and signed the informed consent form.
- Participants who have a GI ≥ 1.3 at baseline.
- Participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns).
- Participants who have an acceptable compliance according to the investigators' assessment.
Who cannot join
- Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics).
- Participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis).
- Participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study.
- Participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment.
- Participants who use other than the recommended mouthrinse or toothpaste during the study period.
- Participants who have moderate and severe chronic or aggressive periodontitis.
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- Participants who have irregularities of the gingival tissues, e. g. hyperplastic gingiva, mucosal diseases.
- Participants who have rampant caries.
- Participants under guardianship or without freedom by administrative or legal award.
- Known hypersensitivity or allergy to the study product and standard toothpaste ingredients used in the present study.
- Known pregnancy or breast feeding during the course of the study.
- Participation in another clinical trial or receipt of an investigational compound/treatment at the same time and 4 weeks prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Saxony, 01109
About this study
Official title: Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.
The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.
Read the detailed description
Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.
- Conditions
- Gingivitis
- Being tested
- amine fluoride/stannous fluoride
- Keywords
- gingivitis index, plaque index, discoloration index, mouth rinse, amine fluoride/stannous fluoride, clinical trial
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amine fluoride/stannous fluorideDrug
Also called meridol
10 ml qd, oral, topical, 6 months duration
| Study group | Role | What they receive |
|---|---|---|
| amine fluoride/stannous fluoride | Experimental | Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene Receives: Drug: amine fluoride/stannous fluoride |
| No rinsing | No intervention | Mechanical oral hygiene only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in gingivitis
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.
Measured: 6 months
Secondary outcomes (4)
Reduction in plaque
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on plaque reduction than mechanical oral hygiene alone.
Measured: 6 months
Discoloration of teeth
To proof the effect of rinsing with ASF on discoloration of teeth
Measured: 6 months
Bacterial colonization
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization
Measured: 6 months
Adverse events
Recording all adverse events over the entire rinsing period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Gaba International AG
- Responsible party
- Sponsor
- Investigators
- Thomas Hoffmann, Prof. Dr., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317446
- Sponsor's protocol ID
- GASAS-1007X
- Status last verified
- Jan 2012
- First submitted
- 16 Mar 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.
- ClinicalTrials.gov ID
- NCT01317446
- Acronym / sponsor ID
- GASAS-1007X
- Conditions
- Gingivitis
- Keywords
- gingivitis index, plaque index, discoloration index, mouth rinse, amine fluoride/stannous fluoride, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Gaba International AG
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Mar 2011 (estimated)
- 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 this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.
Detailed description
Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amine fluoride/stannous fluoride | Experimental | Drug: amine fluoride/stannous fluorideAmine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene |
| No rinsing | No intervention | –Mechanical oral hygiene only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male and female adults aged ≥18 years.
- Participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites > 3.5 mm and < 5 mm).
- Participants must have read, understood and signed the informed consent form.
- Participants who have a GI ≥ 1.3 at baseline.
- Participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns).
Key exclusion criteria (12 listed)
- Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics).
- Participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis).
- Participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study.
- Participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment.
- Participants who use other than the recommended mouthrinse or toothpaste during the study period.
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 |
|---|---|---|
| amine fluoride/stannous fluorideAlso: meridol10 ml qd, oral, topical, 6 months duration | Drug | amine fluoride/stannous fluoride |
Primary outcome
Reduction in gingivitis
Time frame: 6 months
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.
4 secondary outcomes
Reduction in plaque
Time frame: 6 months
Discoloration of teeth
Time frame: 6 months
Bacterial colonization
Time frame: 6 months
Adverse events
Time frame: 6 months
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 18 Jan 2012.
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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.
Thomas Hoffmann, Prof. Dr. principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amine fluoride/stannous fluoride in people with Gingivitis, run by Technische Universität Dresden at 1 site in Germany.
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 6 inclusion and 12 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 18 Jan 2012. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in gingivitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2012.