Effect of a Liquid Toothpaste on Periodontal Disease
Primary Purpose
Periodontitis, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DA-5502 liquid toothpaste
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DA-5502 liquid toothpaste
placebo
Arm Description
SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg. everyday 3 times for 6 weeks
no active ingredients everyday 3 times for 6 weeks
Outcomes
Primary Outcome Measures
gingival index
Secondary Outcome Measures
Plaque index
Clinical attachment level
Bleeding of probing
change of microbial growth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03117153
Brief Title
Effect of a Liquid Toothpaste on Periodontal Disease
Official Title
Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 4, 2014 (Actual)
Primary Completion Date
September 15, 2014 (Actual)
Study Completion Date
February 11, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA-5502 liquid toothpaste
Arm Type
Experimental
Arm Description
SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg.
everyday 3 times for 6 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
no active ingredients
everyday 3 times for 6 weeks
Intervention Type
Other
Intervention Name(s)
DA-5502 liquid toothpaste
Other Intervention Name(s)
DA-5502, Gumguard
Intervention Description
6 weeks study, brush three times daily, liquid toothpaste
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
same flavor solution, brush three times daily
Primary Outcome Measure Information:
Title
gingival index
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Plaque index
Time Frame
6 week
Title
Clinical attachment level
Time Frame
6 week
Title
Bleeding of probing
Time Frame
6 week
Title
change of microbial growth
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Sung Kim, Ph.D
Organizational Affiliation
Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18190554
Citation
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.
Results Reference
background
PubMed Identifier
20109998
Citation
Hu 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.
Results Reference
background
PubMed Identifier
19591338
Citation
Silva 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.
Results Reference
background
PubMed Identifier
21860922
Citation
Charles 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.
Results Reference
background
PubMed Identifier
19591335
Citation
Hernandez-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.
Results Reference
background
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Effect of a Liquid Toothpaste on Periodontal Disease
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