Periodontitis Clinical Trial
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
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 63 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul St.Mary's Hospital | Seocho-Gu | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul St. Mary's Hospital | The Catholic University of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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