An interventional study of Guided Bone Regeneration (GBR) in Ridge Deficiency, sponsored by Samer Faraj. Completed. Open to participants aged 18 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Samer Faraj · Not applicable, Interventional, and Treatment
The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.
Inclusion Criteria: .
Patients included in the study were required:
Exclusion Criteria: Patients were excluded if they :
This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
Procedure: Guided Bone Regeneration (GBR)
This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.
Procedure: Guided Bone Regeneration (GBR)
Teeth Extraction With Bone Grafting and Membrane
Also known as: Ridge Preservation
Alveolar Ridge Dimensional Changes
Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
Time frame: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
Alveolar Ridge Bone Vitality
a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
Time frame: Mean= 19.5 weeks after tooth extraction and bone grafting
Ridge Healing Evaluation
Pictures of the healing ridges were taken using clinical macro lens photography
Time frame: Two weeks form the time of the extraction
No study locations are listed for this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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