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Completed

NCT Number: NCT03648723

The Effect of Periodontal Disease Treatment in Patients With Kidney Disease

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

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Key information

Age range

31 year–65 year

Study type

Observational

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 27, 2018
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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