## Protocol Section
### Identification Module
**NCT ID:** NCT04027179

**Acronym:** TODY

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CAAE17482019.5.0000.5501
#### Organization
**Class:** OTHER
**Full Name:** University of Taubate
### Status Module
#### Completion Date
**Date:** 2022-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2019-07-23

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-08

**Type:** ESTIMATED

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2019-07-19
**Type:** ACTUAL
**Study First Submit Date:** 2019-07-18
**Study First Submit QC Date:** 2019-07-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Taubate

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Periodontitis

- Normal Blood Pressure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Drug: 0.12% chlorhexidine digluconate mouthwash

- Procedure: Periodontal instrumentation

**Label:** FMS chlorhexidine mouthwash

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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).

**Intervention Names:**

- Procedure: Periodontal instrumentation

- Drug: Placebo mouthwash

**Label:** FMS placebo mouthwash

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** Full-mouth scaling and root planning with manual curettes.

**Intervention Names:**

- Procedure: Periodontal instrumentation

**Label:** FMS no mouthwash

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FMS chlorhexidine mouthwash

**Description:** 0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

**Name:** 0.12% chlorhexidine digluconate mouthwash

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- FMS chlorhexidine mouthwash

- FMS no mouthwash

- FMS placebo mouthwash

**Description:** Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.

**Name:** Periodontal instrumentation

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- FMS placebo mouthwash

**Description:** placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

**Name:** Placebo mouthwash

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal

**Measure:** Efficacy - comparative tongue bacterial counts

**Time Frame:** Baseline and 3 months

#### Secondary Outcomes

**Description:** Differences in mean nitrite levels from saliva samples pre- and post-treatment

**Measure:** Safety - comparative nitrite levels in saliva

**Time Frame:** Baseline and 3 months

**Description:** Changes in the percentage of hypertension episode

**Measure:** Safety - Percentage of hypertension episodes

**Time Frame:** Baseline and 3 months

**Description:** Mean changes of DNA methylation statuses in oral cells

**Measure:** Safety - status of DNA methylation in oral cells

**Time Frame:** Baseline and 3 months

**Description:** Changes in the percentage of deep periodontal pockets

**Measure:** Efficacy - Percentage of periodontal pockets

**Time Frame:** Baseline and 6 months

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 35 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taubate

**Country:** Brazil

**Facility:** University of Taubate - Nucleus of periodontal research

**State:** SP

**Zip:** 12020330

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M30405

- Name: Dysbiosis

- Relevance: HIGH

- As Found: Dysbiosis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000064806

- Term: Dysbiosis

### Intervention Browse Module - Ancestors

- ID: D000000891

- Term: Anti-Infective Agents, Local

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000004202

- Term: Disinfectants

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M5953

- Name: Chlorhexidine

- Relevance: HIGH

- As Found: Digital

- ID: M344731

- Name: Chlorhexidine gluconate

- Relevance: HIGH

- As Found: Hesperidin

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

- ID: M7383

- Name: Disinfectants

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002710

- Term: Chlorhexidine

- ID: C000010882

- Term: Chlorhexidine gluconate

### Misc Info Module

- Version Holder: 2024-05-24
