The Effect of Periodontal Disease Treatment in Patients With Kidney Disease

The Comparison of the Effect of Periodontal Treatment in Patients With Diabetic and Non Diabetic Nephropathy

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical parameters change	TNF-α pg/mL serum levels were evaluated.	biochemical parameters were evaluated at baseline and 6 months following periodontal treatment . Change is determined with baseline - 6 months after periodontal treatment.

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Zekeriya Taşdemir, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2016
• Primary Completion (ACTUAL): January 10, 2017
• Study Completion (ACTUAL): May 10, 2017

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: Ztasdemir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No