GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal surgery will shown greater gum and bone regeneration when compare to bone graft substitute alone. Also, to find the optimal dose.
This will be a prospective, randomized, double-blinded, controlled, multi-center, dose-verification clinical study in subjects who require surgical intervention to treat a qualifying periodontal defect. Subjects 25 years and older with advanced periodontal disease in at least one site requiring surgical treatment to correct a bone defect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
University of Alabama at Birmingham
Birmingham, Alabama, United States
Regenerative Solutions
Fullerton, California, United States
Drs. McClain and Schallhorn
Aurora, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.
Time frame: 6 months post-surgery
Change in Clinical Attachment Level at 3 Months
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)
Time frame: Baseline and 3 months post-surgery
Change in Clinical Attachment Level at 6 Months
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)
Time frame: Baseline and 6 months post-surgery
Linear Bone Growth at 6 Months
Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)
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Perio Health Professionals
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Time frame: Baseline and 6 months post-surgery
Percent Bone Fill at 6 Months
Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.
Time frame: Baseline and 6 months post-surgery
Pocket Depth Change at 3 Months
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)
Time frame: Baseline and 3 months post-surgery
Pocket Depth Change at 6 Months
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)
Time frame: Baseline and 6 months post-surgery
Change in Gingival Recession at 3 Months
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)
Time frame: Baseline and 3 months post-surgery
Change in Gingival Recession at 6 Months
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)
Time frame: Baseline and 6 months post-surgery