Guided Bone Regeneration Around Immediate Implants
Condition: Missing Tooth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional
Phase: Phase 4

Summary: 
      An important result of healing after tooth extraction is a reduction in dimensions of the
      remaining bone at that site. This reduction of bone volume precludes successful restoration
      of the space using a dental implant. Bone augmentation has shown promise in clinical reports
      to reduce this loss of bone volume, thus allowing implant placement and restoration. The
      purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone
      regeneration around dental implants placed in fresh extraction sockets.
    

Detailed description: 
      Aim: The purpose of this clinical study is to investigate the effect of a non-resorbable
      polytetrafluoroethylene (PTFE) membrane on immediate implant placement in the esthetic zone.

      Material and Methods: Systemically healthy subjects presenting with a hopeless tooth in the
      maxillary premolar or anterior region will be recruited in the study. Following a minimally
      traumatic tooth extraction, subjects will be randomly distributed into one of two treatment
      groups, a Membrane (Test) or a No Membrane (Control) group. Both groups will receive
      immediate placement of an implant along with placement of a bone graft material to fill the
      spaces around the implant. Sites in the test group will receive a non-resorbable PTFE
      membrane over the socket, whereas those in the control group will receive a collagen dressing
      over the socket. At sites in the test group, the membrane will be removed at 4 weeks. A
      second stage surgery and placement of a provisional restoration will be carried out 4 months
      after implant placement. Final restorations will be placed 3 months after placement of the
      provisional restoration. Clinical and radiographic measurements will be performed at
      baseline, implant placement, placement of provisional and final restorations and at the
      5-month recall visit.
    

Intervention name(s): Minimally Traumatic Tooth Extraction; Immediate Implant Placement; Bone Graft Placement; Membrane placement; Collagen plug placement; Medications
Intervention type(s): Procedure; Device; Biological; Biological; Biological; Drug
Intervention description(s): The surgeon will perform a minimally traumatic tooth extraction in the following fashion. Intrasulcular incisions will be performed with at 15-C scalpel around the tooth to be extracted.
A periotome will then be introduced into the periodontal ligament space in order to sever the subcrestal attachment and expand the periodontal ligament space. Elevators will be used to initiate luxation of teeth. After significant mobility has been achieved through elevation, forceps will be used only to deliver the tooth. Finally, the socket will be curetted to remove all granulomatous tissue and irrigated with sterile isotonic saline solution.; A threaded titanium alloy implant with an internal hex connection and a Resorbable Blast Texturing (RBT) surface (Tapered Internal® Implant System, Biohorizons, Inc., Birmingham, AL, USA) will be placed using a surgical guide. Implant diameter of 3.8mm with lengths of either 12 or 15mm will be used. Implants will be placed approximately 3-4mm below the free gingival margin or 2-3mm below the cemento-enamel junction of adjacent teeth.; Circumferential defects or dehiscences around the immediately placed implant will be grafted. enCore™ Combination Allograft (Osteogenics Biomedical, Lubbock, Texas, USA) will be used as the bone graft material.; A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.; A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket; Patients will be given amoxicillin 500mg 2 days prior to the surgery and will then continue for every 8 hours for 10 days. Patients will also take Ibuprofen 600mg every 6 hours for the first 3 days following the surgery, and then as needed for pain. Patients will also receive a prescription for Vicodin as needed for pain, every 4 to 6 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment