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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03648723
Other study ID # Ztasdemir
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2016
Est. completion date May 10, 2017

Study information

Verified date August 2018
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date May 10, 2017
Est. primary completion date January 10, 2017
Accepts healthy volunteers
Gender All
Age group 31 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Biochemical parameters change TNF-a 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.
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