X-space Implants in Post-extraction Sites.
Condition: Missing Tooth; Osseointegration Failure of Dental Implant
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      Several recent systematic reviews have highlighted how the macrodesign of dental implants can
      influence stress distribution and biomechanical and biological behavior in implants
      immediately inserted in post-extraction sites. Finite element analyzes have confirmed the
      benefit of the inclination of the implant threads in reducing implant displacement in
      post-extraction sites, increasing primary stability, and decreasing stress in contact with
      the trabecular bone.

      Other comparative studies have shown that the design of the threads of the implant does not
      affect the distribution of stress in the surrounding bone.

      In view of the need to evaluate the influence of implant macrodesign in the case of implants
      inserted in post-extraction alveoli, this study will examine the clinical results of two
      different types of implants with different macrodesigns, with the aim of providing scientific
      evidence in this regard.

      The present study will investigate through a randomized controlled trial the effect of thread
      macrodesign of X-space implants on primary stability and osseointegration when inserted in
      post-extraction sites, as compared to cylindric 2P implants.
    

Detailed description: 
      Objectives Evaluate the clinical and radiological performance of a new implant geometry
      (X-space) with a central and apical thread designed to increase the contact surface with the
      alveolar bone and allow a greater insertion torque and better primary stability in
      post-extraction implants.

      The evaluation will be done through:

        -  Estimation of the difference in terms of dimensional changes of the alveolar bone
           between the following implants placed in fresh post-extraction sites: (1) X-space (test
           group), (2) Bone System 2P (control group)

        -  Estimation of primary stability

        -  Estimation of implant failure

        -  Estimation of influences of different clinical factors implant and patient-related to
           the values of the outcomes.

      Expected results The null hypothesis is that the X-space implant is better than the 2P
      implant. Even in the event of non-statistical significance, factors concerning clinical
      significance and secondary variables will be assessed in order to determine the efficiency of
      each of the treatments.

      MATERIALS AND METHODS Study design The study will be a randomized clinical trial with two
      arms, each arm belonging to one of the two intervention groups. The randomization sequence
      will be computer-generated by an independent statistical specialist.

      All the interventions will be performed at the same center by 3 different clinicans following
      the same protocol. Surgeons will be aware of the type of intervention to be performed only
      after tooth extraction, therefore immediately before performing the intervention of interest.

      The type of intervention will be assigned by means of sealed opaque envelopes that will be
      open immediately before the intervention.

      Patients will be provided with adequate and exhaustive information for participation in the
      study and each patient must sign a detailed informed consent.

      All the interventions performed and the procedures followed in this study are in accordance
      with the ethical standards of the committee responsible for human experimentation
      (institutional and national) and with the Helsinki Declaration of 1975, revised in 2000.

      Sample size The sample size was determined for a first type error (alpha) 0.05 and a study
      power of 0.9 (beta 0.1). The reference variable is the dimensional change of the thickness of
      the vestibular crest (measured at the implant platform level).

      The minimal effect of interest assessed from previous studies and the researchers' clinical
      evaluation was established at 1 mm, while the standard deviation was 0.6 mm.

      Considering a 20% loss at follow-up, the sample size required for each group was determined
      at 15 participants, or 30 participants in all.

      References:

      1. Wittes J. Sample size calculation for randomized controlled trials. Epidemiol Rev. Vol 24,
      No. 1, 2002.

      Procedures foreseen by the study Thirty implants (15 X-Space and 15 Bone System Cylindrical
      "2P") of variable diameter and of adequate length will be immediately inserted in the
      post-extraction sites of thirty patients with therapeutic indications for implantation. The
      implants (Bone System, Milan) are produced on machining centers and subjected to rigorous
      cleaning treatments and high precision dimensional checks.

      The Ecotek surface of the Bone System implants boasts a long experience of 25 years of
      clinical applications, Implant surface treatment is obtained by sandblasting with ruby
      corundum and subsequent etching treatment with acids.

      • Surgical protocol In all cases, the extractions will be carried out without lifting the
      flap and preserving the vestibular wall of the alveolus.

      All implants will be inserted at the crest level and will be closed by a screw. The surgical
      procedure requires insertion into the implant tunnel by means of a controlled torque
      micromotor (max 50 Ncm), at a speed of 20/25 rpm; for this purpose it is necessary to have a
      special driver (40120701) inserted in the contra-angle handpiece; for manual insertion with
      controlled torque, a dynamometric ratchet (CRD) with the relative short (40052401) and
      standard (40052501) drivers are available.

      However, the possibility of insertion with a manual screwdriver is maintained, with the usual
      tools already used for the other Bone System implants.

      The post-extraction site will be closed with a collagen membrane and cross suture.

      Data collection methods Variables to be measured (outcomes) Patients will undergo a CT Cone
      Beam examination immediately after implant insertion and 6 months later to evaluate the
      morphological and dimensional changes of the alveolar bone horizontally and vertically around
      the tooth / implant. All the measurements will be carried out in a computerized program which
      will allow to standardize the repeated measurements.

      The measurements on the CT Cone Beam exams and the measurements of the secondary variables
      will be carried out by an operator not aware of the group to which the patients belong (blind
      examiner).

      Criteria for stopping the study

        -  Observation of high difference between the techniques, indicating one technique as more
           efficient than the others or a technique as much less efficient than the other (ethical
           reason).

        -  High number of patients lost at follow-up (greater than expected when calculating the
           sample size).

      Criteria for the exit of the subject from the study

        -  Missing presence at the control at 1 and 3 months (for general evaluation and oral
           hygiene control)

        -  Missed presence at check and measures at 6 months

        -  Lack of collaboration at the oral hygiene level (oral hygiene assessment indices)

        -  Ongoing presence of periodontal diseases or oral mucous membranes. Ongoing presence of
           systemic diseases (or related medical therapies) that may influence bone metabolism and
           tissue healing (e.g. Osteoporosis, corticosteroid therapy, immunodepressive therapies,
           chemotherapy, radiotherapy, etc.).

      Expected duration The foreseeable duration of this study is 18-24 months.

      Statistical data analysis The statistical analyzes will be carried out by a statistical
      analysis expert, on coded and non-identifiable groups. The statistical unit will be the
      patient.

      Descriptive analyzes will be conducted for all demographic variables at the beginning and end
      of therapy. Mann-Whitney test will be used for statistical comparison analyzes of continuous
      variables between independent groups. In addition, several multilevel regression analyzes
      will be conducted to assess the dependence of bone changes on the initial thickness of the
      vestibular wall and on various patient-related variables. For statistical tests the p-value
      will be established at 0.05.
    

Intervention name(s): post-extraction dental implant
Intervention type(s): Procedure
Intervention description(s): Insertion of a dental implant immediately after tooth extraction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial of parallel design with a 1:1 allocation ratio
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: primary stability; dental implant; post-extraction dental implant; dental implant macrodesign; implant failure