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CompletedNCT03117153Updated Apr 17, 2017

Effect of a Liquid Toothpaste on Periodontal Disease

An interventional study of DA-5502 liquid toothpaste and placebo in Periodontitis and Gingivitis, sponsored by Dong-A Pharmaceutical. Completed. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-17.

Sponsored by Dong-A Pharmaceutical · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Aug 2014, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontitis
  • Gingivitis
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 98 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Dong-A Pharmaceutical is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
98 participants (actual)

Study arms

  • 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

  • Placebo comparator
    placebo

    no active ingredients everyday 3 times for 6 weeks

    Other: placebo

Interventions

  • OtherDA-5502 liquid toothpaste

    6 weeks study, brush three times daily, liquid toothpaste

    Also known as: DA-5502, Gumguard

  • Otherplacebo

    same flavor solution, brush three times daily

06

What researchers measure

Primary outcomes

  1. gingival index

    Time frame: 6 week

Secondary outcomes

  1. Plaque index

    Time frame: 6 week

  2. Clinical attachment level

    Time frame: 6 week

  3. Bleeding of probing

    Time frame: 6 week

  4. change of microbial growth

    Time frame: 6 week

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 18190554 ↗
  • 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. PubMed 20109998 ↗
  • 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. PubMed 19591338 ↗
  • 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. PubMed 21860922 ↗
  • 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. PubMed 19591335 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03117153
Lead sponsor
Dong-A Pharmaceutical
Responsible party
Sponsor
First posted
Apr 17, 2017
Start date
Aug 4, 2014
Primary completion
Sep 15, 2014
Completion
Feb 11, 2015
Last update
Apr 17, 2017

Study contacts

Chang-Sung Kim, Ph.D
study director · Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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