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Response to Periodontal Therapy in a Chronic Kidney Disease Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525457
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Maité Souyet, Pontificia Universidad Catolica de Chile

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE May 15, 2018
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE August 6, 2018
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
Change in Clinical Attachment Level (CAL) [ Time Frame: 3 months ]
Change from baseline CAL (in mm) at three months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03525457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
Change in Bleeding on probing (BOP) [ Time Frame: 3 months ]
Change from baseline BOP (%) at three months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response to Periodontal Therapy in a Chronic Kidney Disease Population
Official Title  ICMJE Response to Non Surgical Periodontal Therapy in a Chronic Kidney Disease Population Candidates to Kidney Transplant
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease Stage 5
  • Periodontal Disease
Intervention  ICMJE Procedure: Non Surgical Periodontal Therapy
Non Surgical Periodontal Therapy in 2 to 3 sessions
Study Arms  ICMJE Experimental: Experimental
Non surgical periodontal therapy
Intervention: Procedure: Non Surgical Periodontal Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic kidney disease patients in Stage 5 (candidates to renal transplant)

Exclusion Criteria:

  • Younger than 18 year old.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maite C Souyet, MsC +56978786186 msouyet@gmail.com
Contact: Patricio F Smith, PhD psmithf@uc.cl
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03525457
Other Study ID Numbers  ICMJE 180104004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Maité Souyet, Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maite C Souyet, MsC Pontificia Universidad Catolica de Chile
PRS Account Pontificia Universidad Catolica de Chile
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP