Ridge Preservation Using FDBA and a Collagen Wound Dressing in Molar Sites
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      Currently, it is not known what the dimensional changes might be following a molar site
      extraction which has been grafted with FDBA and covered with a collagen wound dressing. The
      purpose of the proposed study is to examine the clinical healing following ridge preservation
      using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®)
      in a molar extraction site.

      I
    

Detailed description: 
      It is well known that a tooth socket will undergo significant resorption and remodeling
      following tooth extraction. Pietrokovsky and Massler documented alveolar bone dimension
      changes subsequent to tooth extraction forty-five years ago. Schropp et al. evaluated tissue
      changes on models following premolar and molar extractions and concluded that 50% of the
      ridge width was lost within one year following extraction. Two thirds of this resorption
      happened during the first 3 months.

      In addition to alveolar ridge resorption in a horizontal dimension (decrease in width),
      changes in the vertical dimension of the ridge have been documented following tooth
      extraction in a canine model. The healing pattern of the extraction socket observed in the
      preclinical setting was further confirmed in human investigations). A systematic review
      concluded that greater loss of ridge width is to be expected following extraction compared to
      loss of ridge height. Clinical mean reductions of 3.87mm and 1.87mm in ridge width and
      height, respectively, were reported. Radiographically, the mean reduction amounted 1.21mm and
      1.53mm for ridge width and height, respectively. These results were confirmed by another
      systematic review.

      If the extracted tooth is to be replaced, the unfavorable dimensional changes resulting from
      this healing process may necessitate advanced and technique sensitive guided bone
      regeneration (GBR) procedures prior to dental implant placement. In order to avoid GBR and
      limit these dimensional changes, grafting of the extraction socket with or without membrane
      coverage, also called ridge preservation procedure, have been advocated. In order to perform
      ridge preservation, typically, a graft material and some sort of a barrier (e.g.
      non-resorbable and resorbable membranes or collagen wound dressing) are used. A large variety
      of materials are available on the market for the purpose of ridge preservation. No material
      gold standard has yet been identified to date, which would ensure the best dimensional
      stability of the alveolar ridge.

      Current materials used as part of standard care in clinical practice include freeze dried
      bone allograft (FDBA) as a grafting material and a dense polytetrafluroethylene (dPTFE)
      non-resorbable membrane or a collagen wound dressing (Collaplug®, Zimmer Dental, Carlsbad,
      CA) to protect the extraction grafted site. It is currently now known how the use of a
      collagen wound dressing would compare to a non-resorbable membrane (which has been
      documented) and if any would lead to any substantial clinical advantages.

      Therefore, the proposed research project will answer the following question:

      What are the dimensional changes of the hard and soft tissues encountered following molar
      extractions with ridge preservation using FDBA and a collagen wound dressing?
    

Intervention name(s): Ridge preservation; FDBA; Collagen wound dressing
Intervention type(s): Procedure; Device; Device
Intervention description(s): Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously.; Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug); Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)
Other intervention name(s): Socket preservation; Socket grafting
Intervention model: Single Group Assignment
Intervention model description: This study will document the use of standard care treatment using FDA approved material used in an FDA approved fashion.
Masking: None (Open Label)
Primary purpose: Other