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The Effect of Periodontal Disease Treatment in Patients With Kidney Disease

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ClinicalTrials.gov Identifier: NCT03648723
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Zekeriya Tasdemir, TC Erciyes University

Study Description
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Brief Summary:
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

Condition or disease
Periodontal Diseases

Detailed Description:

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

Study Design
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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Comparison of the Effect of Periodontal Treatment in Patients With Diabetic and Non Diabetic Nephropathy
Actual Study Start Date : January 10, 2016
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : May 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Group/Cohort
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)
Non-diabetic nephropathy
This group consisted of diagnosis with nephropathy without diabetes mellitus.


Outcome Measures
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Primary Outcome Measures :
  1. Periodontal disease parameters change [ Time Frame: Examinations were performed at baseline and repeated 6 months following periodontal treatment. Change is determined with at baseline - at 6 months after periodontal treatment. ]
    pocket depth (mm) evaluation .was performed by periodontal probe.


Secondary Outcome Measures :
  1. Biochemical parameters change [ Time Frame: biochemical parameters were evaluated at baseline and 6 months following periodontal treatment . Change is determined with baseline - 6 months after periodontal treatment. ]
    TNF-α pg/mL serum levels were evaluated.


Eligibility Criteria
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Ages Eligible for Study:   31 Years to 65 Years   (Adult, Older Adult)
Sampling Method:   Probability Sample
Study Population
All patients in each groups had to have chronic periodontitis and ≥15 natural teeth; moreover, they needed to be >30 years old. 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 were considered to be exclusion criteria.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648723


Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Zekeriya Taşdemir TC Erciyes University
More Information
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Responsible Party: Zekeriya Tasdemir, Principal investigator, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03648723    
Other Study ID Numbers: Ztasdemir
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases