A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts
Condition: Dental Alveolus; Oral Surgical Procedures, Preprosthetic
Study type: Interventional

Summary: 
      When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of
      bone may make it impossible to place a dental implant. Guided bone regeneration procedures
      are used to re-establish a bone dimension sufficient to place a dental implant. The primary
      objective of the study is to determine whether there is any difference in the gain of
      horizontal alveolar ridge width following guided bone regeneration surgery using a combined
      autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous
      bone has historically been considered the gold standard for alveolar ridge grafting; however,
      other materials including allografts and xenografts have also been used with excellent
      results. This study evaluates the potential benefits, or lack thereof, for using a combined
      autogenous/allograft approach versus an allograft alone. The investigators will clinically
      evaluate the efficacy of this technique and determine the difference in bone formation
      between groups following healing at 5 months by observing bone growth relative to heads of
      the tenting screws placed horizontally in the locations of greatest defect in the alveolar
      ridge. A biopsy of the healed site will be taken at the time of implant placement. The null
      hypothesis is that there will be no difference in the amount of horizontal ridge width gain
      at 5 months post-grafting between the two different grafting materials (allograft alone
      versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that
      histologically, the combination graft (MinerOss®/particulate autograft) will have a similar
      percentage of vital bone present at 5 months compared to the allograft-alone group
      (MinerOss®).
    

Detailed description: 
      Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to
      place a dental implant. The primary objective of the study is to determine whether there is
      any difference in the gain of horizontal alveolar ridge width following guided bone
      regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a
      particulate allograft alone. Autogenous bone has historically been considered the gold
      standard for alveolar ridge grafting; however, other materials including allografts and
      xenografts have also been used with excellent results. This study evaluates the potential
      benefits, or lack thereof, for using a combined autogenous/allograft approach versus an
      allograft alone. The investigators will clinically evaluate the efficacy of this technique
      and determine the difference in bone formation between groups following healing at 5 months
      by observing bone growth relative to heads of the tenting screws placed horizontally in the
      locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken
      at the time of implant placement. The null hypothesis is that there will be no difference in
      the amount of horizontal ridge width gain at 5 months post-grafting between the two different
      grafting materials (allograft alone versus allograft combined with autogenous bone).
      Furthermore, the null hypothesis is that histologically, the combination graft
      (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5
      months compared to the allograft-alone group (MinerOss®).
    

Intervention name(s): allograft alone; allograft with autograft
Intervention type(s): Device; Device
Intervention description(s): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws; use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment