Trial Outcomes & Findings for CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation (NCT NCT00889265)

Recruitment was from June 2009 to February 2011. Subjects were recruited from patients attenting the PI's clinic and had one edentulous site which required lateral ridge augmentation prior to dental implant placement.

All enrolled participants took part in the study.

CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation

The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.

Score Description 1. Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence 2. Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration 3. Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration