Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients (TODY)

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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis; Normal Blood Pressure
• Intervention / Treatment: Drug: 0.12% chlorhexidine digluconate mouthwash; Procedure: Periodontal instrumentation; Drug: Placebo mouthwash

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Taubate, SP, Brazil, 12020330
      • University of Taubate - Nucleus of periodontal research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMS chlorhexidine mouthwash; 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; 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.
Placebo Comparator: FMS placebo mouthwash; 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; 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).
Active Comparator: FMS no mouthwash; Full-mouth scaling and root planning with manual curettes.	Procedure: Periodontal instrumentation; Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Taubate
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dysbiosis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: CAAE17482019.5.0000.5501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No