Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

NCT04027179 | Unknown Phase 4 DMC

• 1 other identifier: CAAE17482019.5.0000.5501
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Periodontitis; Normal Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Efficacy - comparative tongue bacterial counts

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

  Baseline and 3 months

Secondary Outcomes (4)

• Safety - comparative nitrite levels in saliva

  Baseline and 3 months

• Safety - Percentage of hypertension episodes

  Baseline and 3 months

• Safety - status of DNA methylation in oral cells

  Baseline and 3 months

• Efficacy - Percentage of periodontal pockets

  Baseline and 6 months

Study Arms (3)

FMS chlorhexidine mouthwash

EXPERIMENTAL

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; Procedure: Periodontal instrumentation

FMS placebo mouthwash

PLACEBO COMPARATOR

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; Drug: Placebo mouthwash

FMS no mouthwash

ACTIVE COMPARATOR

Full-mouth scaling and root planning with manual curettes.

Procedure: Periodontal instrumentation

Interventions

0.12% chlorhexidine digluconate mouthwash DRUG

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

FMS chlorhexidine mouthwash

Periodontal instrumentation PROCEDURE

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

FMS chlorhexidine mouthwash; FMS no mouthwash; FMS placebo mouthwash

Placebo mouthwash DRUG

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

FMS placebo mouthwash

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- known alergy to chlorhexidine; removable prosthodontics apparatus; pregnant and breast feeding women.

Sponsors & Collaborators

• University of Taubate: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

University of Taubate - Nucleus of periodontal research

Taubaté, São Paulo, 12020330, Brazil

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)