Effect of a Liquid Toothpaste on Periodontal Disease

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117153
• Other study ID #: DA-5502_301
• Status: Completed
• Phase: N/A
• First received: April 10, 2017
• Last updated: April 12, 2017
• Start date: August 4, 2014
• Est. completion date: February 11, 2015

Study information

• Verified date: April 2017
• Source: Dong-A Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 11, 2015
• Est. primary completion date: September 15, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• DA-5502 liquid toothpaste
6 weeks study, brush three times daily, liquid toothpaste
• placebo
same flavor solution, brush three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival index		6 week
Secondary	Plaque index		6 week
Secondary	Clinical attachment level		6 week
Secondary	Bleeding of probing		6 week
Secondary	change of microbial growth		6 week