Effect of a Liquid Toothpaste on Periodontal Disease

Not Applicable

Completed

• Conditions: Periodontitis; Gingivitis
• Interventions: Other: DA-5502 liquid toothpaste; Other: placebo

• Registration Number: NCT03117153
• Lead Sponsor: Dong-A Pharmaceutical

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.

Study Timeline

• Study Start: 2014-08-04
• Primary Completion: 2014-09-15
• Study Completion: 2015-02-11
• Status Verified: 2017-04
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Study First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-5502 liquid toothpaste	DA-5502 liquid toothpaste	SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg. everyday 3 times for 6 weeks
placebo	placebo	no active ingredients everyday 3 times for 6 weeks

Primary Outcome Measures

Name	Time	Method
gingival index	6 week

Secondary Outcome Measures

Name	Time	Method
Plaque index	6 week
Clinical attachment level	6 week
Bleeding of probing	6 week
change of microbial growth	6 week