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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Periodontitis

Intervention / Treatment
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* Other: Bio Mineral toothpaste
* Other: Perio Total Care toothpaste


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perio Total Care toothpaste<br>A Group which use Perio Total Care toothpaste during participation. | Other: Perio Total Care toothpaste<br>* Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once<br>|
| Experimental: Bio Mineral toothpaste<br>A Group which use Bio Mineral toothpaste during participation. | Other: Bio Mineral toothpaste<br>* Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 to 4 weeks | 
| 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). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild periodontitis, Bio Mineral toothpaste, Geumjin Thermal Water