Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis
Single Blind, Randomized, Active-controlled Comparative Clinical Trial to Evaluate Clinical Efficacy and Safety Following the Application for 4 Weeks of Bio Mineral Toothpaste in Patients With Mild Periodontitis
1 other identifier
interventional
60
1 country
1
Brief Summary
The hypothesis of this study is that using "Bio Mineral" toothpaste for 4 weeks will decrease plaque and gingivitis of mild periodontitis patients compared to patients using "Perio Total Care" toothpaste. This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 6, 2013
February 1, 2013
3 months
March 5, 2012
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
0 to 4 weeks
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
0 to 4 weeks
Secondary Outcomes (2)
Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.
0 to 4 weeks
Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.
4 weeks
Study Arms (2)
Perio Total Care toothpaste
ACTIVE COMPARATORA Group which use Perio Total Care toothpaste during participation.
Bio Mineral toothpaste
EXPERIMENTALA Group which use Bio Mineral toothpaste during participation.
Interventions
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
Eligibility Criteria
You may qualify if:
- A healthy man or menopausal woman who is at least 18 to maximum 63 years of age.
- Agreed to participate voluntarily in the study.
- Must have over 20 maxillary teeth
- Must have mild periodontal disease which can induce mild plaque.
- Having no general disease except for dental disease.
- Must be able to understand and carry out the trial's objective and method.
You may not qualify if:
- Who has history of using antimicrobials or antibiotics during the past 30 days.
- Who has history of periodontal treatment during the past 30 days.
- Who has acute pain or severe suppuration caused by pericoronitis of the wisdom tooth.
- Who has hypersensitive conditions caused by Gingivitis or periodontitis.
- Who having restorative dentistry or wearing braces widely.
- Who using tobacco products (Except for who quit smoking)
- Who has been participated in other clinical trials during the past 4 weeks.
- Who judged inappropriate to participate in the study by investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul St. Mary's Hospitallead
- The Catholic University of Koreacollaborator
Study Sites (1)
Seoul St.Mary's Hospital
Seocho-Gu, Seoul, 137701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youngkyung Ko, M.D.
Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 8, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02