Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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.