Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

Not Applicable

Not yet recruiting

• Conditions: Gingivitis; Periodontal Diseases; Hypertension
• Interventions: Procedure: Professional oral hygiene; Behavioral: electric toothbrush

• Registration Number: NCT04328389
• Lead Sponsor: University of L'Aquila

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Study Start: 2024-06
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Professional oral hygiene	Professional oral hygiene	Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session.
Placebo Comparator: electric toothbrush	electric toothbrush	Participats will be instructed to used electric toothbrush for home supragingival plaque removal

Primary Outcome Measures

Name	Time	Method
Systolic and Diastolic Blood Pressure Change	1 week	Ambulatory Blood Pressure Monitoring

Secondary Outcome Measures

Name	Time	Method
Systolic and Diastolic Blood Pressure Change	1 week	Unattented Blood Pressure Measurement