Computer-guided Versus Free- Hand Immediate Implant Placement
Condition: Dental Implant
Study type: Interventional

Summary: 
      Patients with fractured anterior teeth indicated for extraction will be recruited to the
      study. After Extraction of the tooth the socket will be evaluated and if eligible for
      immediate implant placement, implants will be placed either by free hand or computer guided
      technique. The pink esthetic score will be evaluated to be the primary outcome.
    

Detailed description: 
      After diagnosis and history taking the patient will be informed about the sequences of the
      trial. If the patient wishes to participate and fulfills the clinical examination inclusion
      criteria, he/she will be sent to perform a Cone Beam Computer Tomography (CBCT) scan while
      biting on a cotton roll and placing cotton rolls in the vestibule to separate the teeth of
      interest from the opposing dentition and lips respectively.

      Then the investigator will examine the CBCT to ensure the presence of sufficient labial bone.
      Only patients with sufficient labial bone (1.5-2 mm) will be included in the study. If the
      patient has less than 1.5 mm labial bone, he/she won't be eligible for immediate implant
      placement and would be referred to delayed implant placement.

      The eligible patients will be recalled for impression making. The principal investigator will
      do a vacuum stent (2mm hard) on the obtained study cast for temporary crown fabrication after
      the surgery. The tooth or root to be extracted will be modified on the cast and an artificial
      tooth would be placed then the vacuum sheet will be pressed on the cast.

      At this appointment (impression making) the patient will choose a sealed envelope containing
      the allocation either to the computer guided group (test group) or free hand group (control
      group). The patient's name will be written on the envelope to avoid changing the
      randomization process.

      For the test group, the principal investigator (AK) will do virtual planning using Blue Sky ®
      implant planning software. Proper implant size and diameter will be used and a virtual
      surgical guide will be constructed in a Standard Triangulation Language (STL) format and
      exported to a 3D printing machine for printing. After printing the guide would be rechecked
      for adaptation on the study cast. A metallic sleeve will be placed and adapted to the
      surgical guide in the proposed implant site, using adhesive to avoid rotation during surgery.

      Surgical procedure:

      A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on
      the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure
      using lancet, periotome, minimal force and rotational movement.

      After extraction the socket will be examined for intact labial and palatal bone using depth
      probe. If all walls are intact the socket would be eligible for immediate implant placement.

      In the test group, the computer guided surgical guide will be used for implant drilling and
      placement following the manufacture's instructions.

      While in the control group, after tooth or root extraction implants will be placed free hand
      guided by the extraction sockets.

      Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any
      further adjustment would be done immediately in the lab and re-positioned in place. Then the
      vacuum stent will be checked in its place again intraorally, then a chair side tooth colored
      auto-polymerizing resin will be injected into the vacuum sheet corresponding to the implant
      site to construct the temporary crown.

      Then occlusion will be checked in maximum intercuspation and lateral movement to avoid any
      contact with the opposing during the healing period. The patient will be instructed to avoid
      eating or incising any hard food in the surgical site for at least two weeks.

      After a week the patient will be recalled for inspection and postoperative photos to be taken
      for outcome assessment for both groups. And finally after a period of 6 months the patient
      would receive a definitive crown.
    

Intervention name(s): immediate implant placement
Intervention type(s): Procedure
Intervention description(s): A prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome (Nordent Manufacturing Inc. U.S.A), minimal force and rotational movement.
After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: immediate; esthetics