Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

Periodontitis Clinical Trial

— TODY  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04027179
• Other study ID #: CAAE17482019.5.0000.5501
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2020
• Est. completion date: July 2022

Study information

• Verified date: July 2019
• Source: University of Taubate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Normal Blood Pressure
• Periodontitis

Intervention

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).

Locations

Country	Name	City	State
Brazil	University of Taubate - Nucleus of periodontal research	Taubate	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Taubate	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - comparative tongue bacterial counts	Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal	Baseline and 3 months
Secondary	Safety - comparative nitrite levels in saliva	Differences in mean nitrite levels from saliva samples pre- and post-treatment	Baseline and 3 months
Secondary	Safety - Percentage of hypertension episodes	Changes in the percentage of hypertension episode	Baseline and 3 months
Secondary	Safety - status of DNA methylation in oral cells	Mean changes of DNA methylation statuses in oral cells	Baseline and 3 months
Secondary	Efficacy - Percentage of periodontal pockets	Changes in the percentage of deep periodontal pockets	Baseline and 6 months