Response to Periodontal Therapy in a Chronic Kidney Disease Population
August 28, 2018 updated by: Maité Souyet, Pontificia Universidad Catolica de Chile
Response to Non Surgical Periodontal Therapy in a Chronic Kidney Disease Population Candidates to Kidney Transplant
This study will evaluate periodontal and systemic parameters of a cohort of chronic kidney disease (stage 5) patients, before and three months after non-surgical periodontal treatment.
It does not consider a control group.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Dental biofilm is a source of inflammation and infection of periodontal tissues. In the last 20 years the interaction between periodontal infections and systemic conditions has been largely studied, suggesting that the inflammation caused in the periodontal tissues could cause a response in other parts of the body.
Recent studies suggest that there could be an association between periodontal disease and chronic kidney disease.
Study Type
Interventional
Enrollment (Anticipated)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Región Metropolitana
-
Santiago, Región Metropolitana, Chile
- Recruiting
- Clínica Odontológica Docente UC
-
Contact:
- Maite C Souyet, MsC
- Phone Number: +56878786186
- Email: msouyet@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic kidney disease patients in Stage 5 (candidates to renal transplant)
Exclusion Criteria:
- Younger than 18 year old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental
Non surgical periodontal therapy
|
Non Surgical Periodontal Therapy in 2 to 3 sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
Time Frame: 3 months
|
Change from baseline CAL (in mm) at three months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Bleeding on probing (BOP)
Time Frame: 3 months
|
Change from baseline BOP (%) at three months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maite C Souyet, MsC, Pontificia Universidad Catolica de Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Almeida S, Figueredo CM, Lemos C, Bregman R, Fischer RG. Periodontal treatment in patients with chronic kidney disease: a pilot study. J Periodontal Res. 2017 Apr;52(2):262-267. doi: 10.1111/jre.12390. Epub 2016 May 2.
- Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.
- Chambrone L, Foz AM, Guglielmetti MR, Pannuti CM, Artese HP, Feres M, Romito GA. Periodontitis and chronic kidney disease: a systematic review of the association of diseases and the effect of periodontal treatment on estimated glomerular filtration rate. J Clin Periodontol. 2013 May;40(5):443-56. doi: 10.1111/jcpe.12067. Epub 2013 Feb 21.
- Limeres J, Garcez JF, Marinho JS, Loureiro A, Diniz M, Diz P. Early tooth loss in end-stage renal disease patients on haemodialysis. Oral Dis. 2016 Sep;22(6):530-5. doi: 10.1111/odi.12486. Epub 2016 May 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 6, 2018
Primary Completion (ANTICIPATED)
August 1, 2019
Study Completion (ANTICIPATED)
December 1, 2019
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
May 14, 2018
First Posted (ACTUAL)
May 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180104004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.