NCT01785355

Brief Summary

Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

9 years

First QC Date

January 29, 2013

Last Update Submit

July 20, 2019

Conditions

Periodontal DiseaseChronic Kidney Disease

Keywords

periodontal diseaseCKDnutritioninflammationanemia response to ESAquality of lifehemodialysis

Outcome Measures

Primary Outcomes (1)

  • Modification of nutritional status

    SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)

    6 months

Secondary Outcomes (1)

  • Modification of inflammatory status

    6 months

Other Outcomes (3)

  • Modification of periodontal disease index

    3 months

  • Modification of the quality of life, as assessed by SF-36 and OHIP-14

    6 months

  • Modification of anaemia response to epoetin

    6 months

Study Arms (1)

Dental treatment

Assessment of the clinical state of the patient. Professional prophylaxis and removal of calculus. Extraction of hopeless teeth.Education of patient for oral hygiene. Periodic reevaluation.

Other: Dental treatment

Interventions

Dental treatmentOTHER

1. The preliminary stage deals with: * assessment of the clinical state of the patient by completing a detailed dental and periodontal chart * education of the patient regarding correct oral hygiene habits; 2. Phase I Therapy: * plaque control : removal of dental plaque, calculus and root planning; antimicrobial therapy (local or systemic) * evaluation of response to the treatment 3. Phase II Therapy - surgical phase: * extraction of hopeless teeth * evaluation of the surgical results. 4. Maintenance phase: * periodic reevaluation of plaque and calculus and of periodontal conditions.

Dental treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Haemodialyzed patients with Periodontal Disease

You may qualify if:

  • Hemodialyzed patients with periodontal disease

You may not qualify if:

  • Malignancies, Diabetes
  • Patient refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMI "Dr Slusanschi Oana"

Bucharest, Romania

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesRenal Insufficiency, ChronicInflammation

Interventions

Dental Care

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Oana Slusanschi, DMD

    University of Medicine and Pharmacy Bucharest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oana Slusanschi, DMD

CONTACT

+40722266279oanciu@yahoo.com

Liliana Garneata, MD

CONTACT

+40722619358lilianagarna@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMD

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 7, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2021

Study Completion

June 1, 2022

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

RO(1)