Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Tongue Bacterial Dysbiosis Related to Periodontal Therapy on Arterial Pressure Control Based on Salivary Nitrite Availability: a Periodontitis Patients Randomized Controlled Clinical Trial

Conditions
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Periodontitis, Normal Blood Pressure

Intervention / Treatment
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* Drug: 0.12% chlorhexidine digluconate mouthwash
* Procedure: Periodontal instrumentation
* Drug: Placebo mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 natural teeth; chronic periodontitis stages II and III; no systemic medication; non smokers; normal blood pressure; no mouthwash regular use; antibiotics > 3 months prior to study; dental treatment > 3 months prior to study. Exclusion Criteria: - known alergy to chlorhexidine; removable prosthodontics apparatus; pregnant and breast feeding women.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMS chlorhexidine mouthwash<br>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). | Drug: 0.12% chlorhexidine digluconate mouthwash<br>* 0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).<br>Procedure: Periodontal instrumentation<br>* Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.<br>|
| Placebo Comparator: FMS placebo mouthwash<br>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). | Procedure: Periodontal instrumentation<br>* Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.<br>Drug: Placebo mouthwash<br>* placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).<br>|
| Active Comparator: FMS no mouthwash<br>Full-mouth scaling and root planning with manual curettes. | Procedure: Periodontal instrumentation<br>* Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |