Effect of a Liquid Toothpaste on Periodontal Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Gingivitis
• Intervention / Treatment: Other: DA-5502 liquid toothpaste; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: DA-5502, Gumguard
Placebo Comparator: placebo; no active ingredients everyday 3 times for 6 weeks	Other: placebo; same flavor solution, brush three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
gingival index	6 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Plaque index	6 week
Clinical attachment level	6 week
Bleeding of probing	6 week
change of microbial growth	6 week

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical
• Investigators: Study Director: Chang-Sung Kim, Ph.D, Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University

Publications and helpful links

General Publications

• Rawlinson A, Pollington S, Walsh TF, Lamb DJ, Marlow I, Haywood J, Wright P. Efficacy of two alcohol-free cetylpyridinium chloride mouthwashes - a randomized double-blind crossover study. J Clin Periodontol. 2008 Mar;35(3):230-5. doi: 10.1111/j.1600-051X.2007.01187.x. Epub 2008 Jan 5.
• Hu D, Li X, Sreenivasan PK, DeVizio W. A randomized, double-blind clinical study to assess the antimicrobial effects of a cetylpyridinium chloride mouth rinse on dental plaque bacteria. Clin Ther. 2009 Nov;31(11):2540-8. doi: 10.1016/j.clinthera.2009.11.004.
• Silva MF, dos Santos NB, Stewart B, DeVizio W, Proskin HM. A clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride to control established dental plaque and gingivitis. J Clin Dent. 2009;20(2):55-61.
• Charles CA, McGuire JA, Sharma NC, Qaqish J. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model. Braz Oral Res. 2011 Jul-Aug;25(4):338-44. doi: 10.1590/s1806-83242011000400010.
• Hernandez-Cott PL, Elias Boneta A, Stewart B, DeVizio W, Proskin HM. Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in reducing dental plaque. J Clin Dent. 2009;20(2):39-44.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2014
• Primary Completion (Actual): September 15, 2014
• Study Completion (Actual): February 11, 2015

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: DA-5502_301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No