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Effect of a Liquid Toothpaste on Periodontal Disease

Primary Purpose

Periodontitis, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DA-5502 liquid toothpaste
placebo
Sponsored by
Dong-A Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontitis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DA-5502 liquid toothpaste

    placebo

    Arm Description

    SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg. everyday 3 times for 6 weeks

    no active ingredients everyday 3 times for 6 weeks

    Outcomes

    Primary Outcome Measures

    gingival index

    Secondary Outcome Measures

    Plaque index
    Clinical attachment level
    Bleeding of probing
    change of microbial growth

    Full Information

    First Posted
    April 10, 2017
    Last Updated
    April 12, 2017
    Sponsor
    Dong-A Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03117153
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 4, 2014 (Actual)
    Primary Completion Date
    September 15, 2014 (Actual)
    Study Completion Date
    February 11, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dong-A Pharmaceutical

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Gingivitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DA-5502 liquid toothpaste
    Arm Type
    Experimental
    Arm Description
    SMFP 760mg, CPC 50mg, tocopherol acetate 10mg, panthenol 100mg, Dipotassium glycyrrhizinate 20mg. everyday 3 times for 6 weeks
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    no active ingredients everyday 3 times for 6 weeks
    Intervention Type
    Other
    Intervention Name(s)
    DA-5502 liquid toothpaste
    Other Intervention Name(s)
    DA-5502, Gumguard
    Intervention Description
    6 weeks study, brush three times daily, liquid toothpaste
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    same flavor solution, brush three times daily
    Primary Outcome Measure Information:
    Title
    gingival index
    Time Frame
    6 week
    Secondary Outcome Measure Information:
    Title
    Plaque index
    Time Frame
    6 week
    Title
    Clinical attachment level
    Time Frame
    6 week
    Title
    Bleeding of probing
    Time Frame
    6 week
    Title
    change of microbial growth
    Time Frame
    6 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chang-Sung Kim, Ph.D
    Organizational Affiliation
    Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18190554
    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.
    Results Reference
    background
    PubMed Identifier
    20109998
    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.
    Results Reference
    background
    PubMed Identifier
    19591338
    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.
    Results Reference
    background
    PubMed Identifier
    21860922
    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.
    Results Reference
    background
    PubMed Identifier
    19591335
    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.
    Results Reference
    background

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    Effect of a Liquid Toothpaste on Periodontal Disease

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