Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects
30 subjects (15 test and 15 control) diagnosed with moderate to severe periodontitis (Armitage, 1999) will be enrolled in the study and randomized to either the test or the control group. The surgical procedure shall be performed within 15 days from the baseline visit of the subjects and will be the same for both groups. In both groups, the flap is replaced subsequently. In total 5 visits per patient are scheduled in this study. The total study duration for each patient should be 12 +/- 2 weeks. The study devices Emdogain® and Straumann Bone Ceramic are CE-marked, and approved by the FDA. One center in France will participate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
Autogenous bone application during periodontal surgery
Hôtel-Dieu, Université Paris 7 Denis Diderot
Paris, France
Change in Clinical Attachment Level (CAL)
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).
Time frame: Baseline and 12 months
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time frame: Baseline and 6 months
Change in Probing Pocket Depth (PPD)
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Time frame: Baseline and 12 months
Change in Clinical Attachment Level (CAL)
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).
Time frame: Baseline and 6 months
Change in Probing Pocket Depth (PPD)
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Time frame: Baseline and 6 months
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time frame: Baseline and 12 months
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