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Trial record 27 of 32 for:    PANTHENOL

Effect of a Liquid Toothpaste on Periodontal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03117153
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Periodontitis Gingivitis Other: DA-5502 liquid toothpaste Other: placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Liquid Toothpaste on Periodontal Disease : a Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : August 4, 2014
Actual Primary Completion Date : September 15, 2014
Actual Study Completion Date : February 11, 2015

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 Name: DA-5502, Gumguard

Placebo Comparator: placebo

no active ingredients

everyday 3 times for 6 weeks

Other: placebo
same flavor solution, brush three times daily




Primary Outcome Measures :
  1. gingival index [ Time Frame: 6 week ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117153


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

Publications:
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Responsible Party: Dong-A Pharmaceutical
ClinicalTrials.gov Identifier: NCT03117153     History of Changes
Other Study ID Numbers: DA-5502_301
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Gingivitis
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases