Clinical trial NCT03117153: Effect of a Liquid Toothpaste on Periodontal Disease
Official title: Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Gingivitis
Lead sponsor: Dong-A Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2017-04-17
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: gingival index
timeFrame: 6 week
Secondary outcomes:
measure: Plaque index
timeFrame: 6 week
measure: Clinical attachment level
timeFrame: 6 week
measure: Bleeding of probing
timeFrame: 6 week
measure: change of microbial growth
timeFrame: 6 week
Other outcomes:
Locations:
Study officials:
affiliation: Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University
name: Chang-Sung Kim, Ph.D
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
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.