Horizontal Ridge Augmentation in Mandible Usign ROG + ESWT
Condition: Bone Regeneration
Study type: Interventional

Summary: 
      Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge
      deficiencies, allowing to restore such defects in order to place bone-integrated dental
      implants. A few reports exist in the literature about the augmentation of mandibular
      horizontal ridge defects before implant placement. Published studies show a large variability
      of reported results regarding horizontal bone augmentation. This can be due to the use of
      different types of membranes and bone graft materials or a combination thereof. Likewise, an
      important percentage of graft reabsorption is reported. Although this technique is very much
      used, an important number of cases must be re-treated or require placing bone graft during
      implant installation surgery. Techniques are required in order to improve vascularization of
      the grafts during GBR technique with the aim to improve their clinical success. Recent
      studies show great interest on the application of shock waves in oral diseases associated to
      infection and bone loss. The shock waves are acoustic waves that have effects on human
      biological tissues, stimulating the neo-angiogenesis and the development of a hyper
      cellularity, showing repairing characteristics on tissues, and starting regenerative
      processes as a result of metabolism improvement and the increase of local circulation. The
      extra corporeal shock waves can activate the osteoblasts and their precursors and they have
      been widely used in orthopaedics for repairing bone fractures. Several clinical studies have
      shown the effectiveness and safety of shock wave therapy in myocardial revascularization,
      lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated
      injuries of soft tissues. No clinical studies exist that assess its effect on guided bone
      regeneration. The evidence related to the positive effects of the use of shock waves on bone
      regeneration suggests this treatment as a novelty and a promising therapy that combined with
      the GBR technique for the treatment of horizontal defects could have an important impact on
      the potentialization of its clinical effectiveness.
    

Detailed description: 
      General Objective:

      Assessing the efficacy of horizontal augmentation and percentage of reabsorption of bone
      graft material in the technique of guided bone regeneration (GBR), combined with the shock
      wave therapy (SWT) in the horizontal bone reconstruction of mandibular alveolar ridges.

      Type of study:

      Triple blind randomized clinical trial

      Population and sample:

      Twenty six patients of university and private clinical practice, who require augmentation of
      horizontal ridge in the mandible for back placing of an implant, and their compliance with
      inclusion and exclusion criteria, will be assessed.

      Type of analysis:

      Central trend and dispersion (medium and standard deviation) measurements will be obtained.
      Type of data distribution using Shapiro Wilk.

      t-student test between no related groups for assessing bone augmentation. t-paired test
      between related groups for assessing pre and post treatment within the same group.

      t test for proportion difference, in order to assess the percentage of reabsorption of bone
      graft, bone density, bone quality, within a same group.

      Fisher, group comparison.

      A multiple linear regression model will be developed in order to establish if the difference
      among groups is influenced by the initial width of the ridge and the thickness of the soft
      tissue.

      In case of not following a normal distribution, no parametrical tests for related and no
      related groups and logistic regression, will be used.

      The frequencies of adverse effects in each group will be obtained, and compared to the Chi2
      test or the Fisher exact test.

      All the analyses will be made with significance level of 5% (p< 0.05).

      Effect measurements: Relative Risk (RR), Attributable Risk Reduction (ARR), and Necessary
      Number to be Treated (NNT). The augmentation of horizontal volume that allows the
      installation of a ≥4.1 mm implant will be taken as cutting point reference of clinical
      success.

      Expected Results:

        -  Establishing the effect of the shock wave therapy, in combination with guided bone
           regeneration, on the improvement of bone augmentation and the decrease of bone graft
           reabsorption.

        -  Establishing the effect of shock wave therapy, in combination with guided bone
           regeneration, on the improvement of bone quality and density, as well as on decreasing
           the adverse effects.

        -  Acquiring new knowledge in the area of bone reconstruction.

        -  Presentation of results in local and international congresses.

        -  Formation of human resource; mastery graduation paper on Dentistry Science Master.
    

Intervention name(s): ROG; ROG & ESWT
Intervention type(s): Procedure; Procedure
Intervention description(s): Bone width augmentation using bone grafting and membrane non cross linking.; Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shock wave therapy (SWT or ESWT); Guided bone regeneration (GBR); horizontal ridge augmentation