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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03525457
Other study ID # 180104004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 6, 2018
Est. completion date December 2019

Study information

Verified date August 2018
Source Pontificia Universidad Catolica de Chile
Contact Maite C Souyet, MsC
Phone +56978786186
Email msouyet@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date December 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Younger than 18 year old.

Study Design


Intervention

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

Locations

Country Name City State
Chile Clínica Odontológica Docente UC Santiago Región Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Clinical Attachment Level (CAL) Change from baseline CAL (in mm) at three months 3 months
Secondary Change in Bleeding on probing (BOP) Change from baseline BOP (%) at three months 3 months
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