A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      This study will be a randomized clinical trial involving a total of 24 subjects. The
      investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft
      bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated
      with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All
      subjects recruited will have already been approved and treatment planned for extraction +
      implant placement by non-study personnel to avoid any potential conflict of interest. All
      subjects will have radiographs that show the tooth planned for extraction. Each subject will
      be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth
      extraction, subjects will receive a standard site preservation therapy consisted with
      xenograft bone substitute + collagen dressing or the alternative site preservation therapy
      consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month
      healing period, subjects will receive a dental implant in the previous extracted site. During
      the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be
      obtained from the implant site. Biopsy samples will be stored for future histological and
      histochemical analysis. After dental implant placement, all subjects will receive a healing
      abutment for soft tissue healing prior to implant restoration.

      During the 6-month healing time after tooth extraction and site preservation therapy,
      subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning
      for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography
      (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate
      extraction planning and at 6-month post-extraction for volumetric measurement and appropriate
      implant treatment planning.

      Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs.
      6-month healing). CBCT images will be analyzed by non-contact reverse engineering system.
      Soft tissue volumetric analysis will be performed to compare the soft tissue healing between
      BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured
      with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.
    


Intervention name(s): Xenograft bone substitute; Collagen dressing; 3D-collagen matrix
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.; Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.; Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
Other intervention name(s): BioOss Collagen®; HeliPlug®; Mucograft Seal®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental Implants; Bone Grafting