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The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).
This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.12% Clorhexidine with alcohol | Active Comparator | 0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days |
|
| 0.12% Clorhexidine without alcohol | Experimental | 0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days |
|
| control | Placebo Comparator | placebo 15ml every 12 hour for 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12% Clorhexidine with alcohol | Drug | Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index. | The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days). | 24hours |
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Inclusion Criteria:
Exclusion Criteria:
• positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Weidlich, PhD | Federal University of Rio Grande do Sul | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 29, 2016 | |
| Reset | Apr 29, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 29, 2016 | Apr 29, 2016 |
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 |
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|
| placebo | Drug | Use of placebo every 12 hours for 04 days |
|
| 0.12% Clorhexidine without alcohol | Drug | Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days |
|
|
| Amidines |