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

Not Applicable

• Conditions: Periodontitis; Hypertension
• Interventions: Procedure: Dental Hygienization Treatment; Procedure: Intensive Treatment; Drug: Chlorhexidine (Intensive Treatment)

• Registration Number: NCT02131922
• Lead Sponsor: Jagiellonian University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2014-04-28
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-05
• Last Update Submitted: 2014-05-05
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hygenization Treatment	Dental Hygienization Treatment	Basic oral hygiene instructions Supragingival plaque removal
Intensive Treatment	Intensive Treatment	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.
Intensive Treatment	Chlorhexidine (Intensive Treatment)	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Change	3 months	Ambulatory Blood Pressure Monitoring

Secondary Outcome Measures

Name	Time	Method
Flow Mediated Dilatation	3 months	Vascular Function Measurement

Trial Locations

Locations (2)

Jagiellonian University Dental Clinic; 🇵🇱 Krakow, Poland

J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University; 🇵🇱 Krakow, Poland