NCT03117153

Effect of a Liquid Toothpaste on Periodontal Disease

Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Dong-A Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Periodontitis
• Gingivitis

Interventions

Type	Name	Description
OTHER	DA-5502 liquid toothpaste	6 weeks study, brush three times daily, liquid toothpaste
OTHER	placebo	same flavor solution, brush three times daily

Timeline

• Start date: 2014-08-04
• Primary completion: 2014-09-15
• Completion: 2015-02-11
• First posted: 2017-04-17
• Last updated: 2017-04-17