The Effect of Periodontal Disease Treatment in Patients With Kidney Disease

NCT ID: NCT03648723

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-10

Study Completion Date

2017-05-10

Brief Summary

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the purpose of the present study was to compare the effects of non-surgical periodontal therapy by clinical and biochemical parameters on patients undergoing continous ambulatory peritoneal dialysis(CAPD) due to diabetic nephropathy and non-diabetic

Detailed Description

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A new branch of periodontology, defined as "medical periodontology," has been proposed that mentioned the bidirectional relationship between periodontal disease and systemic conditions.

In the lights of these informations, the purpose of the present study was to compare the effects of non-surgical periodontal therapy on patients undergoing continous ambulatory peritoneal dialysis(CAPD) due to diabetic nephropathy and non-diabetic. Forty three participants ( 22 Diabetic Nephropathy(DN) group , 21 Non-Diabetic Nephropathy(N-DN) group) were included and divided into the two group; DN group and N-DN group, in the present study.

The following clinical parameters were evaluated at baseline and the end of the study: Plaque index ; Gingival index ; pocket depth (PD) measurements; bleeding on probing (BOP)-percentage of BOP (+) sites; gingival recession (GR)-from the cement-enamel junction to the gingival margin; and clinical attachment level (CAL)-the sum of PD and GR measurements. The Decay-Missing-Filling Index (DMFT) was recorded. Clinical examinations were repeated 6 months following periodontal treatment. All clinical measurements were taken from the mid-buccal and mid-lingual sites and the buccal aspects of the interproximal contact area for the mesial and distal sites of each tooth to the nearest 0.5 mm using a 15 mm periodontal probe at baseline and the 6th months after treatment. All periodontal clinical examinations were performed by one calibrated examiner (FOT). At baseline and 6 months after treatment, fasting venous blood samples were collected from the antecubital fossa by an experienced nurse. Blood samples for TNF- α, IL-6 and PTX-3 were centrifuged, and separated serum and plasma samples were stored at -80◦C until analysis. TNF-α , IL-6 , and PTX-3 serum levels were determined using a commercial solid-phase enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Periodontal treatments were performed 2 hours after the patients had their breakfast following the blood sampling. Standard oral hygiene instructions were given to all groups, including interdental plaque control (interdental brushes) and brushing of the dorsum of the tongue twice a day. Oral hygiene control and re-instructions were provided during all visits. After local infiltration, full-mouth scaling and root planning (FM-SRP) was performed by the same investigator with standard periodontal curettes

Conditions

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Periodontal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic nephropathy

Diabetic nephropathy is defined by macroalbuminuria that is, a urinary albumin excretion of more than 300 mg in a 24-hour collection or macroalbuminuria and abnormal renal function as represented by an abnormality in serum creatinine, or glomerular filtration rate(GFR)

No interventions assigned to this group

Non-diabetic nephropathy

This group consisted of diagnosis with nephropathy without diabetes mellitus.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* had to have chronic periodontitis
* ≥15 natural teeth
* needed to be \>30 years old

Exclusion Criteria

* History of antibiotic or anti-inflammatory drugs within the previous 6 months
* pregnancy or lactation
* periodontal therapy within 6 months prior to the study
* past or current smoking and alcohol consumption
Minimum Eligible Age

31 Years

Maximum Eligible Age

65 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Zekeriya Tasdemir

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekeriya Taşdemir

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Other Identifiers

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Ztasdemir

Identifier Type: -

Identifier Source: org_study_id

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