Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control (PerioBP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Periodontitis
• Intervention / Treatment: Procedure: Dental Hygienization Treatment; Procedure: Intensive Treatment; Drug: Chlorhexidine (Intensive Treatment)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-121
    • Active, not recruiting
    • J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University
  • Krakow, Poland
    • Recruiting
    • Jagiellonian University Dental Clinic
    • Contact: Marta Czesnikiewicz-Guzik; Phone Number: 66683950; Email: maczesni@yahoo.co.uk
    • Sub-Investigator: Daniel Nowakowski, DMD
    • Principal Investigator: Marta Czesnikiewicz-Guzik, DMD MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Hygenization Treatment; Basic oral hygiene instructions Supragingival plaque removal	Procedure: Dental Hygienization Treatment
Experimental: 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.	Procedure: Intensive Treatment; Intensive Surgical Treatment of Periodontitis; Other Names: Intensive Surgical Treatment of Periodontitis; Drug: Chlorhexidine (Intensive Treatment); Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets

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

Other Outcome Measures

Outcome Measure	Time Frame
Leukocyte Immunophenotype and Cytokine measurement	3 months
Periodontal Health Score - Probing Depth	3 months
Periodontal Health Score - CAL - Clinical Attachment Loss	3 months
The Community Periodontal Index of Treatment Needs Index	3 months
Gingival Index	3 months

Collaborators and Investigators

• Sponsor: Jagiellonian University

Publications and helpful links

General Publications

• Czesnikiewicz-Guzik M, Osmenda G, Siedlinski M, Nosalski R, Pelka P, Nowakowski D, Wilk G, Mikolajczyk TP, Schramm-Luc A, Furtak A, Matusik P, Koziol J, Drozdz M, Munoz-Aguilera E, Tomaszewski M, Evangelou E, Caulfield M, Grodzicki T, D'Aiuto F, Guzik TJ. Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy. Eur Heart J. 2019 Nov 1;40(42):3459-3470. doi: 10.1093/eurheartj/ehz646.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: MOMT-01A