Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control

Study Overview
=================
Brief Summary
-----------------
Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.

Official Title
-----------------
Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control and Vascular Function

Conditions
-----------------
Periodontitis, Hypertension

Intervention / Treatment
-----------------
* Procedure: Intensive Treatment
* Procedure: Dental Hygienization Treatment
* Drug: Chlorhexidine (Intensive Treatment)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Periodontitis with three or more periodontal pockets with a probing depth (PD) > 5mm Bleeding of these periodontal pockets on probing Have at least 20 natural teeth Provide informed consent and willingness to cooperate with the study protocol Age >25 years old Absence of other significant oral infections. Primary Hypertension on stable treatment Exclusion Criteria: Clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks Hospitalization for any reason within the past 3 months; Life expectancy of < 3 years; Allergic disorders; History of chronic infectious disease, Chronic Obstructive Pulmonary Disease (COPD), tuberculosis; chronic hepatitis B or C infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease; Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations) Non-basal cell malignancy or treated myelo or lymphoproliferative disease within the past 5 years; Known HIV positive; Immunizations within past 3 months Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. Primary pulmonary hypertension. Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion. Individual is pregnant or nursing History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Hygenization Treatment<br>Basic oral hygiene instructions Supragingival plaque removal | Procedure: Dental Hygienization Treatment<br> <br> |
| Experimental: Intensive Treatment<br>One-Stage Full-Mouth Disinfection. Scaling and root planing, four quadrants in one session. Extraction of radix relicta. Subgingival chlorhexidine (PerioKIN) (0.2%) in all pockets. Oral hygiene instructions. | Procedure: Intensive Treatment<br>* Intensive Surgical Treatment of Periodontitis<br>* Other names: Intensive Surgical Treatment of Periodontitis;Drug: Chlorhexidine (Intensive Treatment)<br>* Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Change | Ambulatory Blood Pressure Monitoring | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Dilatation | Vascular Function Measurement | 3 months |