Condition category
Oral Health
Date applied
07/11/2010
Date assigned
18/11/2010
Last edited
03/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eduardo Vilela

ORCID ID

Contact details

Rua Dr Geraldo Moutinho 55
Jardins Imperiais
Juiz de Fora
36036348
Brazil
eduardo.vilela@ufjf.edu.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

# 942.248.2006/report # 327/2006

Study information

Scientific title

Impact of treatment of chronic periodontitis on the serum levels of prohepcidin in patients with chronic kidney disease: Interventional controlled clinical assay

Acronym

UFJF

Study hypothesis

We hypothesized that part of the chronic inflammatory response seen in chronic kidney disease (CKD) patients stems from chronic periodontitis (CP), which, through the increase in the expression of inflammatory markers such as interleukin-6 (IL-6), stimulates hepcidin synthesis.

Ethics approval

Ethics Committee in Research on Human Beings from UFJF approved on the 6th of December 2006 (ref: 942.248.2006 / report: 327/2006)

Study design

Interventional controlled clinical assay

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Chronic periodontitis (CP); chronic kidney disease (CKD); Prohepcidin

Intervention

Patients with CP were divided into two groups: CKD patients and controls
Both groups received instructions on oral hygiene techniques, including the manual techniques of tooth and interproximal brushing, and on how to use dental floss and perform supragingival prophylaxis. The nonsurgical periodontal therapy (PT) consisted of radicular scraping and subgingival curettage, using standard instrumentation with Gracey curettes and ultrasound devices performed in 1 hour sessions over an average period of 4 weeks. Local anesthesia was used when necessary.

Upon concluding the periodontal treatment, participants were followed up after 15, 30, 60, and 90 days. At each return visit, instructions on oral hygiene and supragingival phrophylaxis were provided.

Blood samples were collected for biochemical analysis at baseline and 3 months after PT. Venous blood after 12 hours fasting was collected in vacuum tubes between 7:00am and 9:00am. Plasma samples with EDTA/heparin and serum samples were immediately placed in ice, aliquoted within 1 hour and stored at -80C until use.

Results:
The efficacy of PT was proven by the statistically significant decrease in the levels of inflammatory markers and the improvement of clinical parameters of CP observed 3 months after completion of the PT. Prohepcidin, IL-6 and us-PCR levels diminished significantly after PT in both groups. In the control group, besides the decrease in the inflammatory markers, a significant increase could also be observed in the levels of haemoglobin and ferritin associated with PT.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Inflammatory markers, assessed at baseline and 3 months post-PT
1. C-reactive protein (us-CRP)
2. Interleukin-6 (IL-6)
3. Prohepcidin

Secondary outcome measures

Biochemical analyses from blood sample in EDTA, at baseline and 3 months post-PT
1. Complete haemogram (automated Coulter STKS)
2. Serum iron (ferrozine)
3. Ferritin (electrochemiluminescence)
4. Transferrine saturation index (labtest ferrozine)

Overall trial start date

10/08/2008

Overall trial end date

10/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with CP, allocated to one of two groups depending on CKD status
1.1. CKD group:
1.1.1. Patients with CKD at stages 3 to 5 and undergoing conservative treatment
1.1.2. Recruited from the PREVENRIM, a CKD prevention clinic at the Interdisciplinary Nucleus of Studies, Research and Treatment in Nephrology (NIEPEN) of the Universidade Federal de Juiz de Fora (UFJF)
1.2. Control patients:
1.2.1. Patients with no systemic disease from the Periodontology Clinic of the School of Dentistry at UFJF
2. Over 18 years of age, either sex
2. Minimum of 20 natural teeth and without periapical lesions
3. Have received no periodontal, antimicrobial, or anti-inflammatory treatment within the last 6 months
4. Have not used steroids or immunosuppressant drugs within the last 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant exclusion criteria

1. Pregnant or breast feeding women
2. Smokers or ex-smokers who had quit smoking within the last 10 years

Recruitment start date

10/08/2008

Recruitment end date

10/08/2010

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Dr Geraldo Moutinho 55
Juiz de Fora
36036348
Brazil

Sponsor information

Organisation

Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora [UFJF]) (Brazil)

Sponsor details

Rua Dr Geraldo Moutinho 55
Jardins Imperiais
Juiz de Fora
36036348
Brazil

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora [UFJF]) (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21655762

Publication citations

  1. Results

    Vilela EM, Bastos JA, Fernandes N, Ferreira AP, Chaoubah A, Bastos MG, Treatment of chronic periodontitis decreases serum prohepcidin levels in patients with chronic kidney disease., Clinics (Sao Paulo), 2011, 66, 4, 657-662.

Additional files

Editorial Notes