NCT03525457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

May 2, 2018

Last Update Submit

August 28, 2018

Conditions

Keywords

Glomerular filtration ratePeriodontitisChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Change in Clinical Attachment Level (CAL)

    Change from baseline CAL (in mm) at three months

    3 months

Secondary Outcomes (1)

  • Change in Bleeding on probing (BOP)

    3 months

Study Arms (1)

Experimental

EXPERIMENTAL

Non surgical periodontal therapy

Procedure: Non Surgical Periodontal Therapy

Interventions

Non Surgical Periodontal Therapy in 2 to 3 sessions

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Younger than 18 year old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Odontológica Docente UC

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27135778BACKGROUND
  • 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.

    PMID: 20500539BACKGROUND
  • 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.

    PMID: 23432795BACKGROUND
  • 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.

    PMID: 27038430BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicPeriodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMouth DiseasesStomatognathic Diseases

Study Officials

  • Maite C Souyet, MsC

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maite C Souyet, MsC

CONTACT

Patricio F Smith, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MsC

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 15, 2018

Study Start

August 6, 2018

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations