Periodontal DiseasePAROHEMNCT01785355
The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients
An observational study of Periodontal Disease and Chronic Kidney Disease, run by Anemia Working Group Romania at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Periodontal Disease, Chronic Kidney Disease
- What is being tested?
- Dental treatment
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- Sep 2012to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Haemodialyzed patients with Periodontal Disease
Who may be able to join
- Hemodialyzed patients with periodontal disease
Who cannot join
- Malignancies, Diabetes
- Patient refusal to participate
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
CMI "Dr Slusanschi Oana"
Bucharest
Oana Slusanschi, DMD, +40722266279, oanciu@yahoo.com
Oana Slusanschi, DMD
About this study
Official title: Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease
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).
Read the detailed description
Patients will be recruited according to eligibility criteria. Initial oral and general status will be evaluated and recorded. The evaluated parameters are listed at the study description section. Also, quality of life will be assessed by using the SF-36 and OHIP-14 questionnaires.
Patients will undergo a series of dental interventions with the final scope of eliminating all oral inflammation. Participants will also be instructed regarding correct oral hygiene habits.
Following dental and periodontal treatments, the oral and general status will be reassessed and the obtained dat analysed.
- Conditions
- Periodontal Disease, Chronic Kidney Disease
- Being tested
- Dental treatment
- Keywords
- periodontal disease, CKD, nutrition, inflammation, anemia response to ESA, quality of life, hemodialysis
- Medical subject headings
- Periodontal Diseases, Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental treatmentOther
- 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;
- Phase I Therapy:
- plaque control : removal of dental plaque, calculus and root planning; antimicrobial therapy (local or systemic)
- evaluation of response to the treatment
- Phase II Therapy - surgical phase:
- extraction of hopeless teeth
- evaluation of the surgical results.
- Maintenance phase:
- periodic reevaluation of plaque and calculus and of periodontal conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of nutritional status
SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)
Measured: 6 months
Secondary outcomes (1)
Modification of inflammatory status
C Reactive Protein
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anemia Working Group Romania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oana Slusanschi, Anemia Working Group Romania
- Investigators
- Oana Slusanschi, DMD, Principal investigator, University of Medicine and Pharmacy Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785355
- Sponsor's protocol ID
- 005
- Other IDs
- 00022
- Acronym
- PAROHEM
- Status last verified
- Jul 2019
- First submitted
- 29 Jan 2013
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease
- ClinicalTrials.gov ID
- NCT01785355
- Acronym / sponsor ID
- PAROHEM / 005
- Conditions
- Periodontal Disease, Chronic Kidney Disease
- Keywords
- periodontal disease, CKD, nutrition, inflammation, anemia response to ESA, quality of life, hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anemia Working Group RomaniaUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients will be recruited according to eligibility criteria. Initial oral and general status will be evaluated and recorded. The evaluated parameters are listed at the study description section. Also, quality of life will be assessed by using the SF-36 and OHIP-14 questionnaires.
Patients will undergo a series of dental interventions with the final scope of eliminating all oral inflammation. Participants will also be instructed regarding correct oral hygiene habits.
Following dental and periodontal treatments, the oral and general status will be reassessed and the obtained dat analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental treatment | – | Other: Dental treatmentAssessment 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haemodialyzed patients with Periodontal Disease
Key inclusion criteria (1 listed)
- Hemodialyzed patients with periodontal disease
Key exclusion criteria (2 listed)
- Malignancies, Diabetes
- Patient refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental treatment1. 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. | Other | Dental treatment |
Primary outcome
Modification of nutritional status
Time frame: 6 months
SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)
1 secondary outcome
Modification of inflammatory status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oana Slusanschi, DMD principal investigator
University of Medicine and Pharmacy Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease and Chronic Kidney Disease, run by Anemia Working Group Romania at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oana Slusanschi, DMD (+40722266279, oanciu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of nutritional status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.