Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness
Condition: Tooth Loss; Peri-implant Mucosa Defect
MeSH terms: Tooth Loss
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Although little is known about the influence of peri-implant mucosa thickness (PMT) on
      long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental
      implant restorations. While the subepithelial connective tissue graft (sCTG) has been
      recognized as the gold standard for gingival augmentation, several studies have reported
      acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin
      biotype were selected on the basis of an eligibility criteria and randomized to the control
      (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and
      at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis
      suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ
      and recipient site wound dehiscence were measured and recorded in both groups at different
      time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such
      as pain and level of satisfaction with final outcome, were also recorded for all study
      participants.
    

Intervention name(s): Acellular Dermal Matrix; Autologous subepithelial connective tissue graft
Intervention type(s): Drug; Procedure
Intervention description(s): 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
Other intervention name(s): Alloderm®; sCTG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment