Effect of a Liquid Toothpaste on Periodontal Disease

Dong-A Pharmaceutical

Status

Completed

Conditions

Periodontitis

Gingivitis

Treatments

Other: DA-5502 liquid toothpaste

Other: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03117153

DA-5502_301

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.