Clinical trial NCT04027179: Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Periodontitis
Normal Blood Pressure
Lead sponsor: University of Taubate
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-07-19
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy - comparative tongue bacterial counts
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Safety - comparative nitrite levels in saliva
timeFrame: Baseline and 3 months
measure: Safety - Percentage of hypertension episodes
timeFrame: Baseline and 3 months
measure: Safety - status of DNA methylation in oral cells
timeFrame: Baseline and 3 months
measure: Efficacy - Percentage of periodontal pockets
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Taubate
country: Brazil
facility: University of Taubate - Nucleus of periodontal research
state: SP
Study officials:
References: