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

Jagiellonian University

Status: Unknown

Conditions: Hypertension; Periodontitis

Treatments: Drug: Chlorhexidine (Intensive Treatment); Procedure: Dental Hygienization Treatment; Procedure: Intensive Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02131922

MOMT-01A

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Hygenization Treatment

Placebo Comparator group

Description:

Basic oral hygiene instructions Supragingival plaque removal

Treatment:

Procedure: Dental Hygienization Treatment

Intensive Treatment

Experimental group

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.

Treatment:

Procedure: Intensive Treatment

Drug: Chlorhexidine (Intensive Treatment)