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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-5502 liquid toothpaste | Experimental | SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg. everyday 3 times for 6 weeks |
|
| placebo | Placebo Comparator | no active ingredients everyday 3 times for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-5502 liquid toothpaste | Other | 6 weeks study, brush three times daily, liquid toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| gingival index | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | 6 week | |
| Clinical attachment level | 6 week | |
| Bleeding of probing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Sung Kim, Ph.D | Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18190554 | Background | 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. | |
| 20109998 | Background |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| placebo | Other | same flavor solution, brush three times daily |
|
| 6 week |
| change of microbial growth | 6 week |
| 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. |
| 19591338 | Background | 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. |
| 21860922 | Background | 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. |
| 19591335 | Background | 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. |
| D005882 |
| Gingival Diseases |