Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control (PerioBP)
Primary Purpose
Periodontitis, Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intensive Treatment
Dental Hygienization Treatment
Chlorhexidine (Intensive Treatment)
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis
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
Sites / Locations
- J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University
- Jagiellonian University Dental ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Hygenization Treatment
Intensive Treatment
Arm Description
Basic oral hygiene instructions Supragingival plaque removal
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.
Outcomes
Primary Outcome Measures
Blood Pressure Change
Ambulatory Blood Pressure Monitoring
Secondary Outcome Measures
Flow Mediated Dilatation
Vascular Function Measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131922
Brief Title
Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control
Acronym
PerioBP
Official Title
Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control and Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hygenization Treatment
Arm Type
Placebo Comparator
Arm Description
Basic oral hygiene instructions Supragingival plaque removal
Arm Title
Intensive Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intensive Treatment
Other Intervention Name(s)
Intensive Surgical Treatment of Periodontitis
Intervention Description
Intensive Surgical Treatment of Periodontitis
Intervention Type
Procedure
Intervention Name(s)
Dental Hygienization Treatment
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine (Intensive Treatment)
Intervention Description
Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets
Primary Outcome Measure Information:
Title
Blood Pressure Change
Description
Ambulatory Blood Pressure Monitoring
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Flow Mediated Dilatation
Description
Vascular Function Measurement
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Leukocyte Immunophenotype and Cytokine measurement
Time Frame
3 months
Title
Periodontal Health Score - Probing Depth
Time Frame
3 months
Title
Periodontal Health Score - CAL - Clinical Attachment Loss
Time Frame
3 months
Title
The Community Periodontal Index of Treatment Needs Index
Time Frame
3 months
Title
Gingival Index
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Czesnikiewicz-Guzik, MD PhD
Phone
66683950
Email
maczesni@yahoo.co.uk
Facility Information:
Facility Name
J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Jagiellonian University Dental Clinic
City
Krakow
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Czesnikiewicz-Guzik
Phone
66683950
Email
maczesni@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Daniel Nowakowski, DMD
First Name & Middle Initial & Last Name & Degree
Marta Czesnikiewicz-Guzik, DMD MD PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
31504461
Citation
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.
Results Reference
derived
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Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control
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