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Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bio Mineral toothpaste
Perio Total Care toothpaste
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Mild periodontitis, Bio Mineral toothpaste, Geumjin Thermal Water

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A healthy man or menopausal woman who is at least 18 to maximum 63 years of age.
  2. Agreed to participate voluntarily in the study.
  3. Must have over 20 maxillary teeth
  4. Must have mild periodontal disease which can induce mild plaque.
  5. Having no general disease except for dental disease.
  6. Must be able to understand and carry out the trial's objective and method.

Exclusion Criteria:

  1. Who has history of using antimicrobials or antibiotics during the past 30 days.
  2. Who has history of periodontal treatment during the past 30 days.
  3. Who has acute pain or severe suppuration caused by pericoronitis of the wisdom tooth.
  4. Who has hypersensitive conditions caused by Gingivitis or periodontitis.
  5. Who having restorative dentistry or wearing braces widely.
  6. Who using tobacco products (Except for who quit smoking)
  7. Who has been participated in other clinical trials during the past 4 weeks.
  8. Who judged inappropriate to participate in the study by investigator

Sites / Locations

  • Seoul St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Perio Total Care toothpaste

Bio Mineral toothpaste

Arm Description

A Group which use Perio Total Care toothpaste during participation.

A Group which use Bio Mineral toothpaste during participation.

Outcomes

Primary Outcome Measures

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.
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.

Secondary Outcome Measures

Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.
Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.
Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.
Compare Satisfaction of treatment group with Control Group at 4 weeks using Satisfaction Questionnaire. Questionnaire Item Elimination of plaque Feeling of refreshment Amount of bubble. Feeling of flow. Taste and Flavor. Level of cleansing teeth Creamy consistency Each subjects will rate score 0(Very dissatisfied) to 10(Very satisfied) using VAS(Visual Analog Scale).

Full Information

First Posted
March 5, 2012
Last Updated
February 5, 2013
Sponsor
Seoul St. Mary's Hospital
Collaborators
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01548469
Brief Title
Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. 30 patients of treatment group and 30 patients of control group, total 60 patients will be enrolled to this study. Every patients will use investigational toothpaste 2 times everyday for 4 weeks and brush their teeth at least 3 minutes each time with 1ml of toothpaste.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Mild periodontitis, Bio Mineral toothpaste, Geumjin Thermal Water

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perio Total Care toothpaste
Arm Type
Active Comparator
Arm Description
A Group which use Perio Total Care toothpaste during participation.
Arm Title
Bio Mineral toothpaste
Arm Type
Experimental
Arm Description
A Group which use Bio Mineral toothpaste during participation.
Intervention Type
Other
Intervention Name(s)
Bio Mineral toothpaste
Intervention Description
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
Intervention Type
Other
Intervention Name(s)
Perio Total Care toothpaste
Intervention Description
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
Primary Outcome Measure Information:
Title
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
Description
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
Time Frame
0 to 4 weeks
Title
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
Description
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
Time Frame
0 to 4 weeks
Secondary Outcome Measure Information:
Title
Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.
Description
Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.
Time Frame
0 to 4 weeks
Title
Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.
Description
Compare Satisfaction of treatment group with Control Group at 4 weeks using Satisfaction Questionnaire. Questionnaire Item Elimination of plaque Feeling of refreshment Amount of bubble. Feeling of flow. Taste and Flavor. Level of cleansing teeth Creamy consistency Each subjects will rate score 0(Very dissatisfied) to 10(Very satisfied) using VAS(Visual Analog Scale).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngkyung Ko, M.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seocho-Gu
State/Province
Seoul
ZIP/Postal Code
137701
Country
Korea, Republic of

12. IPD Sharing Statement

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Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis

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