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

U

University of Taubate

Status and phase

Unknown
Phase 4

Conditions

Normal Blood Pressure
Periodontitis

Treatments

Procedure: Periodontal instrumentation
Drug: Placebo mouthwash
Drug: 0.12% chlorhexidine digluconate mouthwash

Study type

Interventional

Funder types

Other

Identifiers

NCT04027179
CAAE17482019.5.0000.5501

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

35 to 50 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups, including a placebo group

FMS chlorhexidine mouthwash
Experimental group
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).
Treatment:
Drug: 0.12% chlorhexidine digluconate mouthwash
Procedure: Periodontal instrumentation
FMS placebo mouthwash
Placebo Comparator group
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).
Treatment:
Procedure: Periodontal instrumentation
Drug: Placebo mouthwash
FMS no mouthwash
Active Comparator group
Description:
Full-mouth scaling and root planning with manual curettes.
Treatment:
Procedure: Periodontal instrumentation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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