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

Primary Purpose

Periodontitis, Normal Blood Pressure

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
0.12% chlorhexidine digluconate mouthwash
Periodontal instrumentation
Placebo mouthwash
Sponsored by
University of Taubate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Taubate - Nucleus of periodontal research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

FMS chlorhexidine mouthwash

FMS placebo mouthwash

FMS no mouthwash

Arm 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).

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).

Full-mouth scaling and root planning with manual curettes.

Outcomes

Primary Outcome Measures

Efficacy - comparative tongue bacterial counts
Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal

Secondary Outcome Measures

Safety - comparative nitrite levels in saliva
Differences in mean nitrite levels from saliva samples pre- and post-treatment
Safety - Percentage of hypertension episodes
Changes in the percentage of hypertension episode
Safety - status of DNA methylation in oral cells
Mean changes of DNA methylation statuses in oral cells
Efficacy - Percentage of periodontal pockets
Changes in the percentage of deep periodontal pockets

Full Information

First Posted
July 18, 2019
Last Updated
July 18, 2019
Sponsor
University of Taubate
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT04027179
Brief Title
Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Taubate
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Normal Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMS chlorhexidine mouthwash
Arm Type
Experimental
Arm 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).
Arm Title
FMS placebo mouthwash
Arm Type
Placebo Comparator
Arm 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).
Arm Title
FMS no mouthwash
Arm Type
Active Comparator
Arm Description
Full-mouth scaling and root planning with manual curettes.
Intervention Type
Drug
Intervention Name(s)
0.12% chlorhexidine digluconate mouthwash
Intervention Description
0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).
Intervention Type
Procedure
Intervention Name(s)
Periodontal instrumentation
Intervention Description
Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.
Intervention Type
Drug
Intervention Name(s)
Placebo mouthwash
Intervention Description
placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).
Primary Outcome Measure Information:
Title
Efficacy - comparative tongue bacterial counts
Description
Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Safety - comparative nitrite levels in saliva
Description
Differences in mean nitrite levels from saliva samples pre- and post-treatment
Time Frame
Baseline and 3 months
Title
Safety - Percentage of hypertension episodes
Description
Changes in the percentage of hypertension episode
Time Frame
Baseline and 3 months
Title
Safety - status of DNA methylation in oral cells
Description
Mean changes of DNA methylation statuses in oral cells
Time Frame
Baseline and 3 months
Title
Efficacy - Percentage of periodontal pockets
Description
Changes in the percentage of deep periodontal pockets
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Taubate - Nucleus of periodontal research
City
Taubate
State/Province
SP
ZIP/Postal Code
12020330
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

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