Effect of a Liquid Toothpaste on Periodontal Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-04

Study Completion Date

2015-02-11

Brief Summary

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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.

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Detailed Description

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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

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Periodontitis Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-5502 liquid toothpaste

SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg.

everyday 3 times for 6 weeks

Group Type EXPERIMENTAL

DA-5502 liquid toothpaste

Intervention Type OTHER

6 weeks study, brush three times daily, liquid toothpaste

placebo

no active ingredients

everyday 3 times for 6 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

same flavor solution, brush three times daily

Interventions

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DA-5502 liquid toothpaste

6 weeks study, brush three times daily, liquid toothpaste

Intervention Type OTHER

placebo

same flavor solution, brush three times daily

Intervention Type OTHER

Other Intervention Names

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DA-5502, Gumguard

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes