Effect of a Liquid Toothpaste on Periodontal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03117153|
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis Gingivitis||Other: DA-5502 liquid toothpaste Other: placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study|
|Actual Study Start Date :||August 4, 2014|
|Actual Primary Completion Date :||September 15, 2014|
|Actual Study Completion Date :||February 11, 2015|
Experimental: DA-5502 liquid toothpaste
SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg.
everyday 3 times for 6 weeks
Other: DA-5502 liquid toothpaste
6 weeks study, brush three times daily, liquid toothpaste
Other Name: DA-5502, Gumguard
Placebo Comparator: placebo
no active ingredients
everyday 3 times for 6 weeks
same flavor solution, brush three times daily
- gingival index [ Time Frame: 6 week ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117153
|Study Director:||Chang-Sung Kim, Ph.D||Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University|