Clinical trial NCT03648723: The Effect of Periodontal Disease Treatment in Patients With Kidney Disease
Official title: The Comparison of the Effect of Periodontal Treatment in Patients With Diabetic and Non Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 43
Minimum age (years): 31
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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

Eligibility 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

Primary outcomes:
measure: Periodontal disease parameters change
timeFrame: 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 outcomes:
measure: Biochemical parameters change
timeFrame: biochemical parameters were evaluated at baseline and 6 months following periodontal treatment . Change is determined with baseline - 6 months after periodontal treatment.
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Zekeriya Taşdemir
role: PRINCIPAL_INVESTIGATOR
References: