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Response to Periodontal Therapy in a Chronic Kidney Disease Population

Primary Purpose

Chronic Kidney Disease Stage 5, Periodontal Disease

Status

Unknown status

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Non Surgical Periodontal Therapy

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 5 focused on measuring Glomerular filtration rate, Periodontitis, Chronic kidney disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Younger than 18 year old.

Sites / Locations

Clínica Odontológica Docente UCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Non surgical periodontal therapy

Outcomes

Primary Outcome Measures

Change in Clinical Attachment Level (CAL)

Change from baseline CAL (in mm) at three months

Secondary Outcome Measures

Change in Bleeding on probing (BOP)

Change from baseline BOP (%) at three months

Full Information

NCT ID

NCT03525457

First Posted

May 2, 2018

Last Updated

August 28, 2018

Sponsor

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT03525457

Brief Title

Response to Periodontal Therapy in a Chronic Kidney Disease Population

Official Title

Response to Non Surgical Periodontal Therapy in a Chronic Kidney Disease Population Candidates to Kidney Transplant

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 6, 2018 (Actual)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease Stage 5, Periodontal Disease

Keywords

Glomerular filtration rate, Periodontitis, Chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Non surgical periodontal therapy

Intervention Type

Procedure

Intervention Name(s)

Non Surgical Periodontal Therapy

Intervention Description

Non Surgical Periodontal Therapy in 2 to 3 sessions

Primary Outcome Measure Information:

Title

Change in Clinical Attachment Level (CAL)

Description

Change from baseline CAL (in mm) at three months

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in Bleeding on probing (BOP)

Description

Change from baseline BOP (%) at three months

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic kidney disease patients in Stage 5 (candidates to renal transplant) Exclusion Criteria: Younger than 18 year old.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maite C Souyet, MsC

Phone

+56978786186

msouyet@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Patricio F Smith, PhD

psmithf@uc.cl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maite C Souyet, MsC

Organizational Affiliation

Pontificia Universidad Catolica de Chile

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clínica Odontológica Docente UC

City

Santiago

State/Province

Región Metropolitana

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maite C Souyet, MsC

Phone

+56878786186

msouyet@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27135778

Citation

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.

Results Reference

background

PubMed Identifier

20500539

Citation

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.

Results Reference

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PubMed Identifier

23432795

Citation

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.

Results Reference

background

PubMed Identifier

27038430

Citation

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.

Results Reference

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Response to Periodontal Therapy in a Chronic Kidney Disease Population

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