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| Name | Class |
|---|---|
| The Catholic University of Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perio Total Care toothpaste | Active Comparator | A Group which use Perio Total Care toothpaste during participation. |
|
| Bio Mineral toothpaste | Experimental | A Group which use Bio Mineral toothpaste during participation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio Mineral toothpaste | Other | Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youngkyung Ko, M.D. | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St.Mary's Hospital | Seocho-Gu | Seoul | 137701 | South Korea |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Perio Total Care toothpaste | Other | Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once |
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Compare Satisfaction of treatment group with Control Group at 4 weeks using Satisfaction Questionnaire. Questionnaire Item
Each subjects will rate score 0(Very dissatisfied) to 10(Very satisfied) using VAS(Visual Analog Scale). |
| 4 weeks |