GingivitisPhase 3NCT03047798
The Effect of Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica on Reducing Plaque and Gingivitis
A Phase 3 study testing Mouthrinse in people with Gingivitis and Dental Plaque, run by Seoul National University.
Trial summary
This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque. Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica extracts and the same participants will also use… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Mouthrinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Oct 2014
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults with at least 20 natural permanent teeth
- mild to moderate plaque (≥20% O'Leary index)
- mild gingivitis (20-30% BOP rate).
Who cannot join
- individuals undergoing orthodontic treatment
- individuals having deep periodontal pockets (≥ 6mm at two or more teeth) on more than two teeth
- diabetics
- pregnant or lactating women
- individuals taking antibiotics within the past one month
- individuals who have used any mouthwashes for the past 6 months.
About this study
Official title: Comparative Effects of Aqueous Single-phase and Oil-water Two-phase Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica Extracts on Reducing Gingivitis: a Randomized Clinical Trial
This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque. Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica extracts and the same participants will also use placebo for tooth brushing by cross-over design.
Read the detailed description
This is a randomized clinical intervention study with a cross-over design. The subjects are randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse. The experimental mouthrinses all contain sodium fluoride and the ASM and OTM contain additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts. For the OTM, 50% essential oil is added to create an oil-water two-phase mouthrinse. Subjects are instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen is followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Mouthrinse
- Keywords
- centella asiatica, bamboo salt, magnolia bark, gingivitis, dental plaque, mouthrinse
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthrinseDrug
A randomized clinical intervention study was planned with a cross-over design. The 34 subjects were randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse.
Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
| Study group | Role | What they receive |
|---|---|---|
| aqueous single-phase mouthrinse | Experimental | This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in aqueous single-phase form. Receives: Drug: Mouthrinse |
| oil-water two-phase mouthrinse | Experimental | This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in oil-water two-phase form. Receives: Drug: Mouthrinse |
| Control | Placebo comparator | The control mouthrinse only contained sodium fluoride Receives: Drug: Mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis
Gingival index
Measured: two weeks
Dental plaque
Plaque index
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Jun 2014
- Primary completion30 Sep 2014
- Study completion31 Oct 2014
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- LG Household & Healthcare Ltd.
- Responsible party
- Principal investigator, Seungjae Choi, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047798
- Sponsor's protocol ID
- S-D20140046
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aqueous Single-phase and Oil-water Two-phase Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica Extracts on Reducing Gingivitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03047798
- Acronym / sponsor ID
- S-D20140046
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- centella asiatica, bamboo salt, magnolia bark, gingivitis, dental plaque, mouthrinse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- LG Household & Healthcare Ltd.
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 9 Feb 2017 (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.
This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque. Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica extracts and the same participants will also use placebo for tooth brushing by cross-over design.
Detailed description
This is a randomized clinical intervention study with a cross-over design. The subjects are randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse. The experimental mouthrinses all contain sodium fluoride and the ASM and OTM contain additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts. For the OTM, 50% essential oil is added to create an oil-water two-phase mouthrinse. Subjects are instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen is followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
| Arm | Type | Receives |
|---|---|---|
| aqueous single-phase mouthrinse | Experimental | Drug: MouthrinseThis contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in aqueous single-phase form. |
| oil-water two-phase mouthrinse | Experimental | Drug: MouthrinseThis contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in oil-water two-phase form. |
| Control | Placebo comparator | Drug: MouthrinseThe control mouthrinse only contained sodium fluoride |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults with at least 20 natural permanent teeth
- mild to moderate plaque (≥20% O'Leary index)
- mild gingivitis (20-30% BOP rate).
Key exclusion criteria (6 listed)
- individuals undergoing orthodontic treatment
- individuals having deep periodontal pockets (≥ 6mm at two or more teeth) on more than two teeth
- diabetics
- pregnant or lactating women
- individuals taking antibiotics within the past one month
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 |
|---|---|---|
| MouthrinseA randomized clinical intervention study was planned with a cross-over design. The 34 subjects were randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse. Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen. | Drug | Control, aqueous single-phase mouthrinse, oil-water two-phase mouthrinse |
Primary outcome
Gingivitis
Time frame: two weeks
Gingival index
Dental plaque
Time frame: two weeks
Plaque index
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 9 Feb 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mouthrinse in people with Gingivitis and Dental Plaque, run by Seoul National University.
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 3 inclusion and 6 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Gingivitis (time frame: two weeks). The study lists 2 primary outcomes in all. 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 9 Feb 2017.