Evaluation of β-tricalcium Phosphate/Calcium Sulfate Versus Allografts
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      Thirty healthy patients will be selected from the outpatient clinic of the Oral and
      Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, to be included
      in this study with non-restorable posterior teeth.Patients will be selected according to the
      following criteria: 1) having a non-restorable posterior tooth. 2) being healthy, with no
      systemic diseases that might contraindicate receiving a dental implant. 3) having good oral
      hygiene. 4) aged between 18 to 45 years old. 5) having sufficient alveolar bone volume and
      height at the future implant site.Patients were classified into three groups:

        -  Group I: ten extraction sockets left for normal healing (blood clot).

        -  Group II: ten extraction sockets filled with Alloplast bone grafting material (EthOss,
           Ethoss Regeneration Ltd, Silsden, UK).

        -  Group III: ten extraction sockets filled with Allograft bone grafting
           material.Evaluation and Follow-up

      All patients will be evaluated clinically and radiographically during a follow up period of 4
      months, where the following criteria will be evaluated:

      A- Clinical evaluation:

        -  Patients will be evaluated at 1 week, 4 weeks and 8 weeks.

        -  Clinical evaluations of soft tissue healing, and keratinized tissue replacement will be
           assessed on the basis of the healing index proposed by Landry et al12.

        -  The scores will assess healing on the basis of redness, presence of granulation tissue,
           bleeding, suppuration, and epithelization.

        -  The surgical region will be examined clinically, if there is pain, redness, tissue
           resorption and bone graft stability.

      B- Radiographic evaluation:

        -  Cone Beam Computed Tomography scan will be taken immediately after implant placement,
           and after 12 months.

        -  All patient scans will be taken by a Planmeca ProMax 3D unit (Planmeca OY, Helsinki,
           Finland) using fixed imaging parameter at every scan. All DICOM data will then be
           analyzed using On Demand 3D software (Version 1, Cyber Med, Seoul, South Korea).

        -  The vertical and horizontal measurements will be measured.

        -  The apico-coronal dimension will be calculated, the bottom of the socket will be
           considered the most apical point, whereas the alveolar bone margin will be considered
           the most coronal point of the socket bone wall.

      C- Histological evaluation:

      - Bone samples will be collected with trephine bur before implant placement, then fixed in
      10% neutral buffered formalin for 24 hours, then transferred to 14% neutral buffered
      Ethylenediaminetetraacetic acid (EDTA) for decalcification 13. After confirming adequate
      decalcification, the specimens will be processed and embedded in paraffin blocks in the
      Pathology department, faculty of Medicine, Mansoura university for histological assessment,
      then stained with haematoxylin and eosin (H&E) as a routine stain to evaluate the quality of
      newly formed bone.
    


Intervention name(s): Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).; Allograft bone grafting material.
Intervention type(s): Other; Other
Intervention description(s): After tooth extraction, the tooth socket will begrafted with Alloplast grafting material; After tooth extraction, the tooth socket will be grafted with allograft grafting material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment