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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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Blood pressure control is crucial for individuals' wellbeing. However, many daily aspects such as diet could impair blood pressure control. In addition, many people living under different conditions in different countries are affected by some kind of gum disease. These people experience gingival bleeding, bad breath, teeth mobility and pain. Throughout gum disease development the number of oral germs in the mouth increases including their levels in tongue surface. Oral bacterial are able to convert nitrate widely found in food in nitrite which influences blood pressure. Frequently treatment of gum diseases general combines manual instrumentation with mouthwashes. However, it has been suggested that reduction of oral bacteria by mouthwashes, especially chlorhexidine, is accompanied by decreased conversion of nitrate to nitrite and that this minor nitrite availability would increase blood pressure. Therefore, this is a point to be clarified for patients, physicians and dentists.
This study will investigate the relation between treatment with mouthwashes and blood pressure of patients with destructive gum disease based on nitrite levels in saliva, bacterial levels in tongue and values of arterial blood pressure which will be monitored over 6 months. In addition, usual clinical parameters and alteration of oral cells' DNA will be also monitored overtime. Patients will be treated under local anesthesia and manual instrumentation within 24 hours. They will receive oral care products too. There will be 3 treatment groups (manual instrumentation + chlorhexidine mouthwash [2 times a day for 3 weeks], manual instrumentation + placebo mouthwash [2 times a day for 3 weeks] and manual instrumentation + no mouthwash) and 2 dental appointments before treatment. After treatment, patients will be examined at 7, 14, 21, 90 and 180 days. Saliva, plaque and cell sampling will be fast and by no invasive methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMS chlorhexidine mouthwash | Experimental | Full-mouth scaling and root planning with manual curettes, 20 ml of 0.12% chlorhexidine gluconate mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with 0.12% chlorhexidine gluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). |
|
| FMS placebo mouthwash | Placebo Comparator | Full-mouth scaling and root planning with manual curettes, 20 ml of placebo mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). |
|
| FMS no mouthwash | Active Comparator | Full-mouth scaling and root planning with manual curettes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12% chlorhexidine digluconate mouthwash | Drug | 0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - comparative tongue bacterial counts | Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - comparative nitrite levels in saliva | Differences in mean nitrite levels from saliva samples pre- and post-treatment | Baseline and 3 months |
| Safety - Percentage of hypertension episodes |
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Inclusion Criteria:
Exclusion Criteria:
- known alergy to chlorhexidine; removable prosthodontics apparatus; pregnant and breast feeding women.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Taubate - Nucleus of periodontal research | Taubaté | São Paulo | 12020330 | Brazil |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Periodontal instrumentation | Procedure | Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each. |
|
| Placebo mouthwash | Drug | placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks). |
|
Changes in the percentage of hypertension episode
| Baseline and 3 months |
| Safety - status of DNA methylation in oral cells | Mean changes of DNA methylation statuses in oral cells | Baseline and 3 months |
| Efficacy - Percentage of periodontal pockets | Changes in the percentage of deep periodontal pockets | Baseline and 6 months |