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OpenTrials
Completed

NCT Number: NCT04473209

Serum Resistin Level Following Non-surgical Periodontal Therapy in Diabetic Patients With Chronic Periodontitis

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.

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Key information

Conditions

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11865, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Non-surgical periodontal therapy

Procedure

supra and subgingival debridement

Primary outcomes

  1. serum resistin

    Time frame: 3 months

    ng/ml

Secondary outcomes

  1. C-reactive protein

    Time frame: 3 months

    μg/mL

  2. probing pocket depth

    Time frame: 3 months

    mm

  3. clinical attachment loss

    Time frame: 3 months

    mm

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Jul 16, 2020

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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