Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Periodontitis Normal Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

0.12% chlorhexidine digluconate mouthwash

Intervention Type DRUG

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

Periodontal instrumentation

Intervention Type PROCEDURE

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

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).

Group Type PLACEBO_COMPARATOR

Periodontal instrumentation

Intervention Type PROCEDURE

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

Placebo mouthwash

Intervention Type DRUG

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

FMS no mouthwash

Full-mouth scaling and root planning with manual curettes.

Group Type ACTIVE_COMPARATOR

Periodontal instrumentation

Intervention Type PROCEDURE

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

Interventions

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0.12% chlorhexidine digluconate mouthwash

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

Intervention Type DRUG

Periodontal instrumentation

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

Intervention Type PROCEDURE

Placebo mouthwash

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

Intervention Type DRUG

Eligibility Criteria

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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.