NCT04027179

Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Taubate · Academic / Other
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Periodontitis
• Normal Blood Pressure

Interventions

Type	Name	Description
DRUG	0.12% chlorhexidine digluconate mouthwash	0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).
PROCEDURE	Periodontal instrumentation	Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.
DRUG	Placebo mouthwash	placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-01
• Completion: 2022-07-01
• First posted: 2019-07-19
• Last updated: 2019-07-23

Locations

1 site across 1 country: Brazil