Clinical Trial: Acute-phase Response & Periodontal Treatment in Diabetes Affected 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 Diabetes-affected Subjects: A Randomized Clinical Trial

Brief Summary:

Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach (Q-SRP).

Patients will be seen one day and three months (study completion) after treatment. The 24 hours appointment will be occurring after the entire completion of the FM-SRP or the first quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed within the following 3 weeks.

At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial parameters will be collected. Periodontal parameters will be checked at baseline and at three months.

Main outcome of the study is the level of C-reactive protein 24 hours after treatment.


Detailed Summary:
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
  • Glycemia [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in blood glucose level. Unit of measure: mg/dl
  • Glycated Haemoglobin [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in Glycated haemoglobin. Unit of measure: mmol/mol
  • Insulin [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in Insulin level
  • 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:

  • Full Mouth Plaque Score (FMPS) [ Time Frame: Baseline and 3 months after treatment ]
    Changes in FMPS. Unit of Measure: %
  • Full Mouth Bleeding Score (FMPS) [ 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
  • Glycemia [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in blood glucose level. Unit of measure: mg/dl
  • Glycated Haemoglobin [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in Glycated haemoglobin. Unit of measure: mmol/mol
  • Insulin [ Time Frame: Baseline, 24 hours and 3 months after treatment ]
    Changes in Insulin level
  • 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: %


Information By: University of Pisa

Dates:
Date Received: March 7, 2017
Date Started: June 1, 2016
Date Completion: June 2019
Last Updated: March 21, 2017
Last Verified: March 2017