At a glance
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Comparison of Two Different Surgical Approaches to Increase Peri-Implant Mucosa Thickness: A Randomized Controlled Clinical Trial
In Brief
A Phase 4 clinical trial evaluating Acellular Dermal Matrix and Autologous subepithelial connective tissue graft for Tooth Loss and Peri-implant Mucosa Defect. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults. AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB). Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.
Study Details
Timeline
Interventions
Placement of acellular dermal matrix (Alloderm®) on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach
Placement of autologous subepithelial connective tissue graft on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach