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

Hypertension Clinical Trial

— PerioBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131922
• Other study ID #: MOMT-01A
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: May 5, 2014
• Start date: September 2009
• Est. completion date: September 2014

Study information

• Verified date: May 2014
• Source: Jagiellonian University
• Contact: Marta Czesnikiewicz-Guzik, MD PhD
• Phone: 66683950
• Email: maczesni[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Poland: Jagiellonian University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Periodontitis

Intervention

Procedure:
• Intensive Treatment
Intensive Surgical Treatment of Periodontitis
• Dental Hygienization Treatment

Drug:
• Chlorhexidine (Intensive Treatment)
Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets

Locations

Country	Name	City	State
Poland	J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University	Krakow
Poland	Jagiellonian University Dental Clinic	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Leukocyte Immunophenotype and Cytokine measurement		3 months	No
Other	Periodontal Health Score - Probing Depth		3 months	No
Other	Periodontal Health Score - CAL - Clinical Attachment Loss		3 months	No
Other	The Community Periodontal Index of Treatment Needs Index		3 months	No
Other	Gingival Index		3 months	No
Primary	Blood Pressure Change	Ambulatory Blood Pressure Monitoring	3 months	No
Secondary	Flow Mediated Dilatation	Vascular Function Measurement	3 months	No