NCT03117153

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

April 10, 2017

Last Update Submit

April 12, 2017

Conditions

PeriodontitisGingivitis

Outcome Measures

Primary Outcomes (1)

  • gingival index

    6 week

Secondary Outcomes (4)

  • Plaque index

    6 week

  • Clinical attachment level

    6 week

  • Bleeding of probing

    6 week

  • change of microbial growth

    6 week

Study Arms (2)

DA-5502 liquid toothpaste

EXPERIMENTAL

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

Other: DA-5502 liquid toothpaste

placebo

PLACEBO COMPARATOR

no active ingredients everyday 3 times for 6 weeks

Other: placebo

Interventions

DA-5502 liquid toothpasteOTHER

6 weeks study, brush three times daily, liquid toothpaste

Also known as: DA-5502, Gumguard
DA-5502 liquid toothpaste
placeboOTHER

same flavor solution, brush three times daily

placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 18190554BACKGROUND

  • 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.

    PMID: 20109998BACKGROUND

  • 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.

    PMID: 19591338BACKGROUND

  • 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.

    PMID: 21860922BACKGROUND

  • 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.

    PMID: 19591335BACKGROUND

MeSH Terms

Conditions

PeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Chang-Sung Kim, Ph.D

    Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 17, 2017

Study Start

August 4, 2014

Primary Completion

September 15, 2014

Study Completion

February 11, 2015

Last Updated

April 17, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share