Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

University of L'Aquila

Status: Not yet enrolling

Conditions: Hypertension; Periodontal Diseases; Gingivitis

Treatments: Procedure: Professional oral hygiene; Behavioral: electric toothbrush

Study type: Interventional

Funder types: Other

Identifiers

NCT04328389

AQ2020

Details and patient eligibility

About

Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated hypertension
• Have at least 20 natural teeth
• Presence of any form of periodontal diseases according to guidelines
• Absence of other significant oral infections.

Exclusion criteria

• Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
• Individual is pregnant or nursing
• Primary pulmonary hypertension
• Professional oral hygine within past 6 months
• Flu, rhinitis, sinusitis etc. within past 4 weeks
• Use of antibiotics within past 4 weeks
• Hospitalization for any reason within the past 3 months
• Allergic disorders; History of chronic infectious disease,
• Chronic hepatitis B or C infection
• Chronic Obstructive Pulmonary Disease (COPD), tuberculosis
• Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
• Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
• History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Placebo Comparator: electric toothbrush

Placebo Comparator group

Description:

Participats will be instructed to used electric toothbrush for home supragingival plaque removal

Treatment:

Behavioral: electric toothbrush

Professional oral hygiene

Experimental group

Description:

Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session.

Treatment:

Procedure: Professional oral hygiene