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Clinical Trials/NCT04473209
NCT04473209CompletedNot Applicable

The Effect of Non-surgical Periodontal Therapy on Serum Resistin Level in Chronic Periodontitis Patients With or Without Type 2 Diabetes Mellitus

Cairo University2 sites in 1 country30 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
serum resistin

Study Overview

Brief Summary

non-surgical periodontal debridement was performed for diabetic patients with chronic periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum resistin level was assessed in the two groups before and after periodontal therapy and also was compared to a healthy control group.

Detailed Description

Background: Resisitin is a recognized marker for chronic inflammatory conditions that could be directly linked with type 2 diabetes mellitus. The aim of this study was to assess serum resistin level in type 2 diabetic patients with chronic periodontitis.

Methods: Forty individuals were recruited in this study and were divided into three groups, diabetic group consisted of 15 diabetic patients (type 2 diabetes mellitus) with moderate to severe chronic periodontitis, non-diabetic group consisted of 15 non-diabetic patients with moderate to severe chronic periodontitis and healthy group consisted of 10 non-diabetic individuals with healthy periodontium. Non-surgical periodontal therapy with supra and subgingival debridement was performed for the diabetic and non-diabetic groups. Pocket depth, clinical attachment level, plaque index, gingival index, serum Resistin and high sensitivity C-Reactive Protein assay were recorded for both groups before and after treatment, while HbA1c was recorded for the diabetic group.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • diagnosed with moderate to severe chronic periodontitis.
  • Presence of a minimum of 15 natural teeth
  • Presence of at least four teeth with one or more sites with probing pocket depth (PPD) ≥5mm and clinical attachment level (CAL) ≥4mm
  • agreement to participate in the study and sign a written informed consent

Exclusion Criteria

  • Patients who received any periodontal treatment or professional scaling and root planing of the teeth for at least 6 months prior to the study initiation
  • A history of antibiotics therapy and anti-inflammatory drugs within the previous 6 months
  • Pregnancy or use of contraceptives or any medication related to diabetes
  • former or current smokers ˂ 5 years.

Outcomes

Primary Outcomes

serum resistin

Time Frame: 3 months

ng/ml

Secondary Outcomes

  • probing pocket depth(3 months)
  • C-reactive protein(3 months)
  • clinical attachment loss(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Weam Ahmed Elbattawy

Dr. Principal Investigator

Cairo University

Study Sites (2)

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