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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21655762
Publication citations
-
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.