NCT03648723

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 22, 2018

Last Update Submit

August 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Biochemical parameters change

    biochemical parameters were evaluated at baseline and 6 months following periodontal treatment . Change is determined with baseline - 6 months after periodontal treatment.

Study Arms (2)

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.

Eligibility Criteria

Age31 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • had to have chronic periodontitis
  • ≥15 natural teeth
  • needed to be \>30 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Zekeriya Taşdemir

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 27, 2018

Study Start

January 10, 2016

Primary Completion

January 10, 2017

Study Completion

May 10, 2017

Last Updated

August 27, 2018

Record last verified: 2018-08