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Completed

NCT Number: NCT03117153

Effect of a Liquid Toothpaste on Periodontal Disease

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DA-5502 liquid toothpaste

Other

6 weeks study, brush three times daily, liquid toothpaste

Other names: DA-5502, Gumguard

Placebo

Other

same flavor solution, brush three times daily

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

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 17, 2017
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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