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

NCT ID: NCT02131922

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Periodontitis Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hygenization Treatment

Basic oral hygiene instructions Supragingival plaque removal

Group Type PLACEBO_COMPARATOR

Dental Hygienization Treatment

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Intensive Treatment

Intervention Type PROCEDURE

Intensive Surgical Treatment of Periodontitis

Chlorhexidine (Intensive Treatment)

Intervention Type DRUG

Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets

Interventions

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Intensive Treatment

Intensive Surgical Treatment of Periodontitis

Intervention Type PROCEDURE

Dental Hygienization Treatment

Intervention Type PROCEDURE

Chlorhexidine (Intensive Treatment)

Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets

Intervention Type DRUG

Other Intervention Names

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Intensive Surgical Treatment of Periodontitis

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Guzik

Prof. dr hab. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University

Krakow, , Poland

Site Status ACTIVE_NOT_RECRUITING

Jagiellonian University Dental Clinic

Krakow, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marta Czesnikiewicz-Guzik, MD PhD

Role: CONTACT

Facility Contacts

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Marta Czesnikiewicz-Guzik

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31504461 (View on PubMed)

Other Identifiers

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MOMT-01A

Identifier Type: -

Identifier Source: org_study_id

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