NCT02131922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

5 years

First QC Date

April 28, 2014

Last Update Submit

May 5, 2014

Conditions

PeriodontitisHypertension

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Change

    Ambulatory Blood Pressure Monitoring

    3 months

Secondary Outcomes (1)

  • Flow Mediated Dilatation

    3 months

Other Outcomes (5)

  • Leukocyte Immunophenotype and Cytokine measurement

    3 months

  • Periodontal Health Score - Probing Depth

    3 months

  • Periodontal Health Score - CAL - Clinical Attachment Loss

    3 months

  • +2 more other outcomes

Study Arms (2)

Hygenization Treatment

PLACEBO COMPARATOR

Basic oral hygiene instructions Supragingival plaque removal

Procedure: Dental Hygienization Treatment

Intensive Treatment

EXPERIMENTAL

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 TreatmentDrug: Chlorhexidine (Intensive Treatment)

Interventions

Intensive TreatmentPROCEDURE

Intensive Surgical Treatment of Periodontitis

Also known as: Intensive Surgical Treatment of Periodontitis
Intensive Treatment
Dental Hygienization TreatmentPROCEDURE
Hygenization Treatment
Chlorhexidine (Intensive Treatment)DRUG

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

Intensive Treatment

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Individual is pregnant or nursing
  • History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Krakow, 31-121, Poland

ACTIVE NOT RECRUITING

Jagiellonian University Dental Clinic

Krakow, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31504461DERIVED

MeSH Terms

Conditions

PeriodontitisHypertension

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Marta Czesnikiewicz-Guzik, MD PhD

CONTACT

66683950maczesni@yahoo.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr hab. med.

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 6, 2014

Study Start

September 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

PL(2)