The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to periodontal surgery without Straumann® Emdogain.
The following secondary endpoints will be evaluated during the study: * Change in Gingival Margin (GM) at 12 months after surgery compared to baseline * Change in Probing Pocket Depth (PPD) at 12 months after surgery compared to baseline * Comparison of early wound healing index (EHI) at 4 weeks after surgery between treatment groups * Comparison of post-surgical pain at 4 weeks after surgery between treatment groups * Change in Bleeding on Probing (BoP) at 12 months after surgery compared to baseline * Change in root dentin hypersensitivity at 12 months after surgery compared to baseline * Change in full mouth plaque index (PI) at 12 months after surgery compared to baseline
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
Periodontal surgery with the additional use of Straumann® Emdogain
Periodontal surgery alone
University of Alabama at Birmingham
Birmingham, Alabama, United States
Clinical Attachment Level
The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM.
Time frame: 12 Months
Change in Gingival Margin (GM) From Baseline to 12 Months
GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ.
Time frame: 12 months after baseline
Change in Probing Pocket Depth (PPD) From Baseline to 12 Months
PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth.
Time frame: 12 months after baseline
Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline
Postoperative wound healing was assessed by the EHI according to Wachtel et al. \[2003\] by visual assessment: 1. complete flap closure - no fibrin line in the interproximal area 2. complete flap closure - fine fibrin line in the interproximal area 3. complete flap closure - fibrin clot in the interproximal area 4. incomplete flap closure - partial necrosis of the interproximal tissue 5. incomplete flap closure - complete necrosis of the interproximal tissue The outcome measure was the percentage of EHI category 1 (complete flap closure - no fibrin line in the interproximal area)
Time frame: 4 weeks after baseline
Comparison of Post-surgical Pain at 4 Weeks After Baseline
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Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome
Time frame: 4 weeks after baseline
Change in Bleeding on Probing (BoP) From Baseline to 12 Months
The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP.
Time frame: 12 months after baseline
Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months
RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH.
Time frame: 12 months after baseline
Change in Plaque Index (PI) From Baseline to 12 Months
The PI was recorded according to O'Leary et al. \[1972\] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI.
Time frame: 12 months after baseline