Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

Study Overview
=================
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.

Official Title
-----------------
Periodontal Management in Hypertensive Patients

Conditions
-----------------
Periodontal Diseases, Gingivitis, Hypertension

Intervention / Treatment
-----------------
* Behavioral: electric toothbrush
* Procedure: Professional oral hygiene


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator: electric toothbrush<br>Participats will be instructed to used electric toothbrush for home supragingival plaque removal | Behavioral: electric toothbrush<br>* Participants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque<br>|
| Experimental: Professional oral hygiene<br>Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session. | Procedure: Professional oral hygiene<br>* Professional oral hygiene using ultrosound scaling and root planing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and Diastolic Blood Pressure Change | Ambulatory Blood Pressure Monitoring | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and Diastolic Blood Pressure Change | Unattented Blood Pressure Measurement | 1 week |