Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness
Condition: Tooth Loss; Peri-implant Mucosa Defect
MeSH terms: Tooth Loss
Intervention: Acellular Dermal Matrix; Autologous subepithelial connective tissue graft
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age: 18 to 80 years.

          -  Subjects must be able and willing to follow instructions related to the study
             procedures.

          -  Subjects must have read, understood and signed an informed consent form.

          -  At least one single-tooth edentulous site, with adjacent natural teeth, planned for
             tooth replacement therapy with an implant-supported restoration.

        Exclusion criteria:

          -  Reported allergy or hypersensitivity to any of the products to be used in the study.

          -  Severe hematologic disorders, such as hemophilia or leukemia.

          -  Active severe infectious diseases that may compromise normal healing.

          -  Liver or kidney dysfunction/failure.

          -  Currently under cancer treatment or within 18 months from completion of radio- or
             chemotherapy.

          -  Subjects with uncontrolled diabetes, defined as Hba1c > 6.5% (According to the
             American Diabetes Association 2014 Guidelines)

          -  Pregnant women or nursing mothers.

          -  Smokers: Subjects who have smoked within 6 months of study onset.

          -  Concomitant medications for systemic conditions that may affect the outcomes of the
             study.

          -  Any other non-specified reason that from the point of view of the investigators will
             make a candidate not a suitable subject for the study (e.g. limited mouth opening).