Response to Periodontal Therapy in a Chronic Kidney Disea... | NCT03525457

Studies
Response to Periodontal Therapy in a Chronic Kidney Disease Population

NCT03525457

Sponsor

Pontificia Universidad Catolica de Chile

Status

Unknown status

Last Update Posted

Aug 31, 2018Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Chronic Kidney Disease Stage 5
Periodontal Disease

Interventions

Non Surgical Periodontal Therapy

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2018Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 2, 2018

First Submission Date that Met QC Criteria

May 14, 2018

First Posted Date

May 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2018

Last Update Posted Date

Aug 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maité Souyet, DDS, MsC, Pontificia Universidad Catolica de ChilePrincipal Investigator

Lead Sponsor

Pontificia Universidad Catolica de ChileOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Non surgical periodontal therapy	Procedure: Non Surgical Periodontal Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non Surgical Periodontal Therapy	Procedure	Non Surgical Periodontal Therapy in 2 to 3 sessions	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Clinical Attachment Level (CAL)	Change from baseline CAL (in mm) at three months	3 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Bleeding on probing (BOP)	Change from baseline BOP (%) at three months	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Younger than 18 year old.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maite C Souyet, MsC	Contact	+56978786186		msouyet@gmail.com
Patricio F Smith, PhD	Contact			psmithf@uc.cl

Overall Officials

Name	Affiliation	Role
Maite C Souyet, MsC	Pontificia Universidad Catolica de Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica Odontológica Docente UC	Recruiting	Santiago	Santiago Metropolitan		Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27135778	Background	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.
20500539	Background	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D010510	Periodontal Diseases
D010518	Periodontitis

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases