Clinical Trial: Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.

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

Official Title:

Brief Summary: This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.

Detailed Summary: Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.
Sponsor: University of Sao Paulo

Current Primary Outcome: Horizontal clinical attachment level (HCAL) [ Time Frame: baseline and 6 months after surgical procedure ]

The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  • Discomfort Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  • Edema Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  • Hematoma Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  • Root Hypersensitivity Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  • Daily Activities Interference Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  • Vertical clinical attachment level (VCAL) [ Time Frame: baseline and 6 months ]
    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
  • Probing pocket depth (PPD) [ Time Frame: baseline and 6 months ]
    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures
  • Gingival recession [ Time Frame: baseline and 6 months ]
    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: March 26, 2014
Date Started: March 2012
Date Completion:
Last Updated: March 29, 2014
Last Verified: March 2014