Clinical Trial: Acute-phase Response & Periodontal Treatment in Obese Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Obese Subjects: A Randomized Clinical Trial

Brief Summary: The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical periodontal treatment in obese patients affected by periodontitis.

Detailed Summary:

Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on obese patients with periodontitis.

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment.

Treatment will be provided using both hand and ultrasonic instrumentation with fine tips.

FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.

Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.


Sponsor: University of Pisa

Current Primary Outcome: Levels C-Reactive Protein [ Time Frame: Baseline, 24 hours and 3 months after treatment ]

Changes in C reactive protein (CRP). Unit of measure: mg/L


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Full Mouth Plaque Score (FMPS) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in FMPS. Unit of Measure: %
  • Full Mouth Bleeding Score (FMBS) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in FMBS. Unit of Measure: %
  • Pocket probing depth (PPD) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in PPD. Unit of Measure: mm
  • Clinical attachment level (CAL) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in CAL. Unit of Measure: mm
  • Recession of the gingival margin (REC) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in REC. Unit of Measure: mm
  • Triglycerides [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in triglycerides. Unit of measure: mmol/L
  • Low-density lipoprotein (LDL) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in LDL. Unit of measure: mmol/L
  • High-density lipoprotein (HDL) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in HDL. Unit of measure: mmol/L
  • Cholesterol [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in total cholesterol. Unit of measure: mmol/L
  • Glycaemia [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in blood glucose level; Unit of measure: mg/dL
  • Glycated Hemoglobin [ Time Frame: Baseline and 3 months after treatment ]
    Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol
  • Insulin [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in Insulin level; Unit of measure: μU/mL
  • Systolic Blood Pressure (SBP) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in SBP; Unit of measure: mmHg
  • Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in DBP; Unit of measure: mmHg
  • Endothelial Function [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %


Original Secondary Outcome: Same as current

Information By: University of Pisa

Dates:
Date Received: March 8, 2017
Date Started: June 1, 2016
Date Completion: January 1, 2020
Last Updated: April 18, 2017
Last Verified: April 2017