Clinical Trial: Acute Phase Response & Periodontal Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial

Brief Summary: This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of periodontal disease. The primary aim was to compare the differences in CRP acute increase following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included changes in a broad array of inflammatory and endothelial injury markers between groups. Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical periodontal therapy performed within 24 hours induced greater perturbations of systemic inflammation compared to conventional treatment.

Detailed Summary:

Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation.

Material & Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months. Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will be performed.


Sponsor: University of Pisa

Current Primary Outcome: C reactive Protein [ Time Frame: 24 Hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • C reactive Protein [ Time Frame: 7 days, 90 days ]
  • Tumor Necrosis Factor - alpha [ Time Frame: 24 Hours, 7 days, 90 days ]
  • Interleukin - 6 [ Time Frame: 24 Hours, 7 days, 90 days ]
  • periodontal pocket depth (PPD) [ Time Frame: 90 days ]
    mean in mm
  • periodontal pocket depth (PPD) [ Time Frame: 90 days ]
    mean in site > 4mm
  • clinical attachment level (CAL) [ Time Frame: 90 days ]
    mean in mm
  • number of pockets > 4 mm [ Time Frame: 90 days ]
    number of pockets > 4 mm
  • Full Mouth Plaque Score [ Time Frame: 90 days ]
    presence/absence of dental plaque in percentual values
  • Full Mouth Bleeding Score [ Time Frame: 90 days ]
    presence/absence of sites bleeding on probing in percentual values


Original Secondary Outcome: Same as current

Information By: University of Pisa

Dates:
Date Received: May 28, 2015
Date Started: May 2012
Date Completion:
Last Updated: May 30, 2015
Last Verified: May 2015