PeriodontitisNCT03117153
Effect of a Liquid Toothpaste on Periodontal Disease
A study testing DA-5502 liquid toothpaste in people with Periodontitis and Gingivitis, run by Dong-A Pharmaceutical.
Trial summary
The aim of the present clinical study is to evaluate the efficacy and safety of the novel toothpaste in patients diagnosed with gingivitis and/or periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis
- What is being tested?
- DA-5502 liquid toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2014to 11 Feb 2015
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- Initial gingivitis index of 1.1~2.0 as determined by the use of the Loe and Silness Gingival Index.
- Signed Informed Consent Form.
Who cannot join
- initial plaque index <1.5, gingival index <1.0
- smoker
- Chronic disease (uncontrolled diabetes, liver disease, heart disease, kidney disease..)
- subject who had hemorrhagic medical history or who take antiplatelet agent or anticoagulant
- subject who need antibiotics for preventive administration
- subjects who had preventive treatment or treatment for periodontitis in the last three months
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- Use of orthodontic appliances.
- Pregnant women or women who are breast feeding.
- Previous participation in any other clinical trial in the last 30 days
- Judged unsuitable by investigators for other reasons.
About this study
Official title: Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study
The aim of the present clinical study is to evaluate the efficacy and safety of the novel toothpaste in patients diagnosed with gingivitis and/or periodontitis.
Read the detailed description
The trial was a randomized, double-blind, placebo-controlled, parallel group, single-center(Department of periodontology, Yonsei University Dental Hospital) study.
98 patients were assessed for eligibility. Since two patients did not meet the inclusion criteria, 96 subjects were randomly assigned to either the test group.The test group was provided a liquid toothpaste and a control group received placebo. At the end of the study, results were analyzed for 87 patients : 42 in the test group and 45 in the control group .
The study protocol requested 4 visits- once every two weeks-of each subjects in the center. At the baseline, subjects were randomly allocated to the test group or the control group. Scaling and tooth brushing instruction were performed and all of the clinical parameters were evaluated. At the 2- and 4-week examinations, clinical parameters of GI, PI were evaluated and at the 6-week examination, all of the clinical parameters were evaluated.
Also, Microbiological quantitative analysis of this procedure was performed at the baseline and 6-week examinations.
- Conditions
- Periodontitis, Gingivitis
- Being tested
- DA-5502 liquid toothpaste, placebo
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5502 liquid toothpasteOther
Also called DA-5502, Gumguard
6 weeks study, brush three times daily, liquid toothpaste
placeboOther
same flavor solution, brush three times daily
| Study group | Role | What they receive |
|---|---|---|
| DA-5502 liquid toothpaste | Experimental | SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg.
everyday 3 times for 6 weeks Receives: Other: DA-5502 liquid toothpaste |
| placebo | Placebo comparator | no active ingredients
everyday 3 times for 6 weeks Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index
Measured: 6 week
Secondary outcomes (4)
Plaque index
Measured: 6 week
Clinical attachment level
Measured: 6 week
Bleeding of probing
Measured: 6 week
change of microbial growth
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start4 Aug 2014
- Primary completion15 Sep 2014
- Study completion11 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Sung Kim, Ph.D, Study director, Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117153
- Sponsor's protocol ID
- DA-5502_301
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rawlinson A, Pollington S, Walsh TF, Lamb DJ, Marlow I, Haywood J, Wright P. Efficacy of two alcohol-free cetylpyridinium chloride mouthwashes - a randomized double-blind crossover study. J Clin Periodontol. 2008 Mar;35(3):230-5. doi: 10.1111/j.1600-051X.2007.01187.x. Epub 2008 Jan 5.
PubMed 18190554Hu D, Li X, Sreenivasan PK, DeVizio W. A randomized, double-blind clinical study to assess the antimicrobial effects of a cetylpyridinium chloride mouth rinse on dental plaque bacteria. Clin Ther. 2009 Nov;31(11):2540-8. doi: 10.1016/j.clinthera.2009.11.004.
PubMed 20109998Silva MF, dos Santos NB, Stewart B, DeVizio W, Proskin HM. A clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride to control established dental plaque and gingivitis. J Clin Dent. 2009;20(2):55-61.
PubMed 19591338Charles CA, McGuire JA, Sharma NC, Qaqish J. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model. Braz Oral Res. 2011 Jul-Aug;25(4):338-44. doi: 10.1590/s1806-83242011000400010.
PubMed 21860922Hernandez-Cott PL, Elias Boneta A, Stewart B, DeVizio W, Proskin HM. Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in reducing dental plaque. J Clin Dent. 2009;20(2):39-44.
PubMed 19591335
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03117153
- Acronym / sponsor ID
- DA-5502_301
- Conditions
- Periodontitis, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Dong-A PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2014 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 11 Feb 2015 (actual)
- First posted
- 17 Apr 2017 (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 aim of the present clinical study is to evaluate the efficacy and safety of the novel toothpaste in patients diagnosed with gingivitis and/or periodontitis.
Detailed description
The trial was a randomized, double-blind, placebo-controlled, parallel group, single-center(Department of periodontology, Yonsei University Dental Hospital) study.
98 patients were assessed for eligibility. Since two patients did not meet the inclusion criteria, 96 subjects were randomly assigned to either the test group.The test group was provided a liquid toothpaste and a control group received placebo. At the end of the study, results were analyzed for 87 patients : 42 in the test group and 45 in the control group .
The study protocol requested 4 visits- once every two weeks-of each subjects in the center. At the baseline, subjects were randomly allocated to the test group or the control group. Scaling and tooth brushing instruction were performed and all of the clinical parameters were evaluated. At the 2- and 4-week examinations, clinical parameters of GI, PI were evaluated and at the 6-week examination, all of the clinical parameters were evaluated.
Also, Microbiological quantitative analysis of this procedure was performed at the baseline and 6-week examinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-5502 liquid toothpaste | Experimental | Other: DA-5502 liquid toothpasteSMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg. everyday 3 times for 6 weeks |
| placebo | Placebo comparator | Other: placebono active ingredients everyday 3 times for 6 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good general health.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- Initial gingivitis index of 1.1~2.0 as determined by the use of the Loe and Silness Gingival Index.
- Signed Informed Consent Form.
Key exclusion criteria (10 listed)
- initial plaque index <1.5, gingival index <1.0
- smoker
- Chronic disease (uncontrolled diabetes, liver disease, heart disease, kidney disease..)
- subject who had hemorrhagic medical history or who take antiplatelet agent or anticoagulant
- subject who need antibiotics for preventive administration
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 |
|---|---|---|
| DA-5502 liquid toothpasteAlso: DA-5502, Gumguard6 weeks study, brush three times daily, liquid toothpaste | Other | DA-5502 liquid toothpaste |
| placebosame flavor solution, brush three times daily | Other | placebo |
Primary outcome
gingival index
Time frame: 6 week
4 secondary outcomes
Plaque index
Time frame: 6 week
Clinical attachment level
Time frame: 6 week
Bleeding of probing
Time frame: 6 week
change of microbial growth
Time frame: 6 week
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 17 Apr 2017.
- Background: PubMed 18190554Rawlinson A, Pollington S, Walsh TF, Lamb DJ, Marlow I, Haywood J, Wright P. Efficacy of two alcohol-free cetylpyridinium chloride mouthwashes - a randomized double-blind crossover study. J Clin Periodontol. 2008 Mar;35(3):230-5. doi: 10.1111/j.1600-051X.2007.01187.x. Epub 2008 Jan 5.
- Background: PubMed 20109998Hu D, Li X, Sreenivasan PK, DeVizio W. A randomized, double-blind clinical study to assess the antimicrobial effects of a cetylpyridinium chloride mouth rinse on dental plaque bacteria. Clin Ther. 2009 Nov;31(11):2540-8. doi: 10.1016/j.clinthera.2009.11.004.
- Background: PubMed 19591338Silva MF, dos Santos NB, Stewart B, DeVizio W, Proskin HM. A clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride to control established dental plaque and gingivitis. J Clin Dent. 2009;20(2):55-61.
- Background: PubMed 21860922Charles CA, McGuire JA, Sharma NC, Qaqish J. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model. Braz Oral Res. 2011 Jul-Aug;25(4):338-44. doi: 10.1590/s1806-83242011000400010.
- Background: PubMed 19591335Hernandez-Cott PL, Elias Boneta A, Stewart B, DeVizio W, Proskin HM. Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in reducing dental plaque. J Clin Dent. 2009;20(2):39-44.
- 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.
Chang-Sung Kim, Ph.D study director
Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University
Questions about this trial
What is this clinical trial studying?
A study testing DA-5502 liquid toothpaste in people with Periodontitis and Gingivitis, run by Dong-A Pharmaceutical.
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 4 inclusion and 10 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 17 Apr 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.
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?
gingival index (time frame: 6 week). 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 NCT03117153, which also lists 5 linked publications.
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 17 Apr 2017.