Impact of treatment of chronic periodontitis on the serum levels of prohepcidin in patients with chronic kidney disease
| ISRCTN | ISRCTN59866656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59866656 |
| Secondary identifying numbers | # 942.248.2006/report # 327/2006 |
- Submission date
- 07/11/2010
- Registration date
- 18/11/2010
- Last edited
- 03/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Eduardo Vilela
Scientific
Scientific
Rua Dr Geraldo Moutinho 55
Jardins Imperiais
Juiz de Fora
36036348
Brazil
| eduardo.vilela@ufjf.edu.br |
Study information
| Study design | Interventional controlled clinical assay |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet. |
| Scientific title | Impact of treatment of chronic periodontitis on the serum levels of prohepcidin in patients with chronic kidney disease: Interventional controlled clinical assay |
| Study acronym | UFJF |
| Study objectives | 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(s) | Ethics Committee in Research on Human Beings from UFJF approved on the 6th of December 2006 (ref: 942.248.2006 / report: 327/2006) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/08/2008 |
| Completion date | 10/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 56 |
| Key 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 |
| Key exclusion criteria | 1. Pregnant or breast feeding women 2. Smokers or ex-smokers who had quit smoking within the last 10 years |
| Date of first enrolment | 10/08/2008 |
| Date of final enrolment | 10/08/2010 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Dr Geraldo Moutinho 55
Juiz de Fora
36036348
Brazil
36036348
Brazil
Sponsor information
Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora [UFJF]) (Brazil)
University/education
University/education
Rua Dr Geraldo Moutinho 55
Jardins Imperiais
Juiz de Fora
36036348
Brazil
"ROR" |
https://ror.org/04yqw9c44 |
|---|
Funders
Funder type
University/education
Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora [UFJF]) (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | Yes | No |
