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Response to Periodontal Therapy in a Chronic Kidney Disease Population

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Unknown status
CT.gov ID
NCT03525457
Collaborator
(none)
65
Enrollment
1
Location
1
Arm
15.8
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Non Surgical Periodontal Therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Response to Non Surgical Periodontal Therapy in a Chronic Kidney Disease Population Candidates to Kidney Transplant
Actual Study Start Date :
Aug 6, 2018
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Non surgical periodontal therapy

Procedure: Non Surgical Periodontal Therapy
Non Surgical Periodontal Therapy in 2 to 3 sessions

Outcome Measures

Primary Outcome Measures

  1. Change in Clinical Attachment Level (CAL) [3 months]

    Change from baseline CAL (in mm) at three months

Secondary Outcome Measures

  1. Change in Bleeding on probing (BOP) [3 months]

    Change from baseline BOP (%) at three months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Chronic kidney disease patients in Stage 5 (candidates to renal transplant)
Exclusion Criteria:
  • Younger than 18 year old.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clínica Odontológica Docente UC Santiago Región Metropolitana Chile

Sponsors and Collaborators

  • Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Maite C Souyet, MsC, Pontificia Universidad Catolica de Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maité Souyet, DDS, MsC, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT03525457
Other Study ID Numbers:
  • 180104004
First Posted:
May 15, 2018
Last Update Posted:
Aug 31, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maité Souyet, DDS, MsC, Pontificia Universidad Catolica de Chile
Glomerular filtration rate
Periodontitis
Chronic kidney disease
Additional relevant MeSH terms:
Periodontal Diseases
Kidney Diseases
Renal Insufficiency, Chronic

Study Results

No Results Posted as of Aug 31, 2018