10.59987/ads/2014.4.136-141
Aim. The aim of this study is to present 18 months follow-up results of porous tantalum trabecular metal-enhanced titanium dental implant (PTTM) in implant supported prosthesis in postoncological patients.
Materials and methods. A total of 25 PTTM implants were placed in each jaw of 6 patients that met specific inclusion and exclusion criteria. Resonance Frequency Analysis (RFA) was conducted and Implant stability was recorded in ISQ values (Osstell ISQ, Osstell AB, Goteborg, Sweden) at implant placement and after 2,4,6,12 and 18 months of functional loading. Mean bone loss was also evaluated at the same interval of time on each periapical radiographs, bone levels were calculated by measuring the distance from the implant shoulder to the first bone to implant contact.
Results. Cumulative implant survival rate is 100% (n=25/25) to date and mean ISQ values recorded were: 72.14±5.61 (range= 50-81) at surgery, 64.39±8.12 (range=44-74) after 2 months, 74.26±7.14 range=44-74) after 4 months, 76.84±7.65 (range=60-83) after 6 months, 78.13±4.14 (range=64-84) after 12 months and 80.22±6.23 (range=68-89) after 18 months of functional loading. Mean crestal marginal bone loss was 0.19±0.25 mm after 2 months of functional loading on periapical radiographs, 0.22±0.4 mm at 4 months, 0.3±0.46 mm at 6 months, 0.57±0.62 at 1 year and 0.64±0.60 mm after 18 months.
Conclusions. The results of this study, even if limited by the number of implants placed indicate that PTTM dental implants have a clinical efficacy in prosthetic rehabilitation of post-oncological patients, due to trabecular structure of the porous Ta metal that increases bone-implant connection values.
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Annali di stomatologia
prosthetic rehabilitation
Clinical evaluation with 18 months follow-up of new PTTM enhanced dental implants in maxillo-facial post-oncological patients
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Clinical evaluation with 18 months follow-up of new PTTM enhanced dental implants in maxillo-facial post-oncological patients
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                                                                                                 Original article



    Clinical evaluation with 18 months follow-up of new
    PTTM enhanced dental implants in maxillo-facial
    post-oncological patients




                                                                                                    i
                                                                                                  al
                                                                                               on
    Piero Papi, DDS                                       apical radiographs, 0.22±0.4 mm at 4 months,
    Sara Jamshir, DDS                                     0.3±0.46 mm at 6 months, 0.57±0.62 at 1 year and
    Edoardo Brauner, DDS, PhD                             0.64±0.60 mm after 18 months.
    Stefano Di Carlo, MD, DDS                             Conclusions. The results of this study, even if
    Antonio Ceci, DDS                                     limited by the number of implants placed indicate




                                                                                     zi
    Luca Piccoli, DDS                                     that PTTM dental implants have a clinical efficacy
    Giorgio Pompa, MD, DDS                                in prosthetic rehabilitation of post-oncological
                                                          patients, due to trabecular structure of the porous




                                                                       na
                                                          Ta metal that increases bone-implant connection
    Department of Oral and Maxillo-Facial Sciences,       values.
    “Sapienza” University of Rome, Italy
                                                          Key words: trabecular metal, PTTM dental im-




                                                            er
                                                          plants, oral cancer, prosthetic rehabilitation.
    Corresponding author:
    Piero Papi, DDS
    Department of Oral and Maxillo-Facial Sciences,       Introduction
    “Sapienza” University of Rome, Italy


                                                     t
    Via Campania, 6
    00161, Rome, Italy
                                                  In      The treatment for patients with a malignant neoplasia
                                                          of the oral cavity requires the cooperation of a team of
    Phone: +393934360087                                  different specialists that follow the patient through the
    E-mail: papi.piero@gmail.com                          phases of diagnosis, therapy and oral rehabilitation.
                                                          Ablative surgery is followed by a reconstructive phase
                                      ni
                                                          after which the patient may need to undergo radio-
    Summary                                               therapy, a condition that may compromise the suc-
                                                          cess of oral rehabilitation (1-3).
                              io

    Aim. The aim of this study is to present 18           Radiotherapy side effects may include mucositis, xe-
    months follow-up results of porous tantalum tra-      rostomia, damage of the salivary glands and osteora-
    becular metal-enhanced titanium dental implant        dionecrosis, which could lead the surgeons to pro-
    (PTTM) in implant supported prosthesis in post-       ceed to a partial jaw resection (4-6). Chemotherapy
                      iz



    oncological patients.                                 side effects are similar to those of radiotherapy and,
    Materials and methods. A total of 25 PTTM im-         usually, is possible to perform dental surgery safely
    plants were placed in each jaw of 6 patients that     before and after chemotherapy if the patient is not
          Ed




    met specific inclusion and exclusion criteria. Res-   further compromised by also undergoing bisphospho-
    onance Frequency Analysis (RFA) was conducted         nate drug therapy (7, 8).
    and Implant stability was recorded in ISQ values      The options for a prosthetic rehabilitation are either
    (Osstell ISQ, Osstell AB, Goteborg, Sweden) at        the tooth-supported prosthesis or implant-supported
    implant placement and after 2,4,6,12 and 18           overdenture (4, 5). However, deformation to the oral
    months of functional loading.                         structures, by surgical treatments, may prevent a
IC




    Mean bone loss was also evaluated at the same         proper osseointegration and result in failure and also
    interval of time on each periapical radiographs,      conventional tissue-supported restorations may lead
    bone levels were calculated by measuring the dis-     to soft tissue management problems (6, 9-13).
    tance from the implant shoulder to the first bone     Over the years numerous implant surfaces and coat-
C




    to implant contact.                                   ings have been utilized to try to maximize on-growth
    Results. Cumulative implant survival rate is 100%     potential and secondary stability, increasing bone to
    (n=25/25) to date and mean ISQ values recorded        implant connection values (BIC).
    were: 72.14±5.61 (range= 50-81) at surgery,           Improvement in surface roughness can be achieved by
©




    64.39±8.12 (range=44-74) after 2 months, 74.26±7.14   using Microtextured, Acid Etched, Sand Blasted/Acid
    (range=44-74) after 4 months, 76.84±7.65 (range=60-   Etched, Phosphate Enriched, Hydoxyapatite (HA), Tita-
    83) after 6 months, 78.13±4.14 (range=64-84) after    nium Plasma Spray (TPS), or Nanotexturized implant
    12 months and 80.22±6.23 (range=68-89) after 18       surfaces.
    months of functional loading.                         These surfaces promote the adherence of platelets
    Mean crestal marginal bone loss was 0.19±0.25         from the initial clot that releases platelet-derived
    mm after 2 months of functional loading on peri-      growth factors (PDGFs), which are chemotactic and

    136                                                                     Annali di Stomatologia 2014; V (4): 136-141
    Clinical evaluation with 18 months follow-up of new PTTM enhanced dental implants in maxillo-facial post-oncological
    patients

    mitogenic for mesenchymal cells and osteoblast                aminations were scheduled respectively 7,14 and 28
    progenitor cells (14).                                        days after surgery and then once a month (1/30 days)
    The current implant surface treatment seems to im-            for the following 18 months.
    prove osteoblastic activities and reduces peri-implant        The definitive restorations were made in a period be-
    bone loss, however 100% Bone to Implant Contact is            tween 2 and 3 months post surgery.




                                                                                                          i
    not achievable because gaps and voids may occur               Resonance Frequency Analysis (RFA) was conduct-




                                                                                                        al
    along the surface.                                            ed and Implant stability was recorded in ISQ values
    A porous tantalum trabecular metal (PTTM), known              (Osstell ISQ, Osstell AB, Goteborg, Sweden) at im-
    commercially as Trabecular Metal Material (Trabecu-           plant placement and after 2,4,6,12 and 18 months of




                                                                                                     on
    lar Metal Technology, Zimmer Inc., Parsippany, NK,            functional loading.
    USA), used since 1998 in orthopaedic reconstruc-              Standardized (Rinn, Dentsply, York, PA, USA) peri-
    tions, has been adapted for dental implant use to             apical radiographs were taken for each implant at
    achieve higher BIC values and bone ingrowth (15-18).          placement and after 2, 4, 6, 12 and 18 months of
    The aim of this study is to evaluate the clinical efficacy    functional loading.




                                                                                            zi
    of porous tantalum trabecular metal-enhanced titani-          Mean bone loss was also evaluated with the same time
    um dental implant (PTTM) in implant-supported pros-           interval on each periapical radiograph, bone levels
    thesis in oral-maxillofacial post-oncological patients.       were calculated by measuring the distance from the im-




                                                                               na
                                                                  plant shoulder to the first bone to implant contact.

    Materials and methods
                                                                  Results




                                                                    er
    This study was open to all patients that met specific in-
    clusion and exclusion criteria (Tab. 1) and that signed       Cumulative implant survival rate is 100% (n=25/25) to
    informed consent, according to the World Medical As-          date and all implants had at least 18 months of clini-
    sociation’s Declaration of Helsinki.                          cal follow-up after functional loading (Figs. 1, 2, 3).
    Six patients were enrolled in this study, 4 female


                                                             t    No serious complications or adverse reactions were
    (66,66%) and 2 male (33,34%) with a mean age of
    55±25,45 years (age range 37-74), they were all post-
                                                          In      reported and all implants were stable and well os-
                                                                  seointegrated.
    oncologic patients treated for oral cancer (Tab. 2).          Mean ISQ values recorded were: 72.14±5.61 at
    The inclusion criteria did not distinguish between pa-        surgery, 64.39±8.12 after 2 months, 74.26±7.14 after
    tients receiving radiotherapy and non-irradiated pa-          4 months, 76.84±7.65 after 6 months, 78.13±4.14 af-
                                                  ni
    tients, when radiotherapy was used it was included in         ter 12 months and 80.22±6.23 after 18 months of
    the medical record.                                           functional loading (Tab. 5).
    A total of 25 PTTM implants were placed in a period           Mean crestal marginal bone loss was 0.19±0.25 mm
                                     io

    between June and July 2012. Each subject was treat-           after 2 months of functional loading on periapical ra-
    ed with a number of implants based on their clinical          diographs, 0.22±0.4 mm at 4 months, 0.3±0.46 at 6
    need, bone quantity and quality (Tabs. 3, 4).                 months, 0.57±0.62 at 1 year and 0.64±0.60 after 18
    For prophylaxis, one hour before surgery antibiotics          months (Tab. 6).
                           iz



    were given to the patients: 2 g of amoxicillin and
    clavulanic acid (Augmentin®, Roche S.p.A., Milan,
    Italy). Chlorhexidinedigluconate 0,12% mouth wash             Discussion
           Ed




    (Dentosan® Collutorio Trattamento Mese, Recordati
    S.p.A., Milano, Italy) was prescribed every day for 7         ISQ results showed an optimal primary stability of the
    days after surgery. Patients were provided with writ-         PTTM dental implants thanks to the trabecular structure
    ten instructions for oral hygiene and were recom-             of the porous Ta metal, which is similar to cancellous
    mended to follow a soft diet for 4 to 5 days post             bone. High initial ISQ results remained constant over
    surgery. Written consent for implant treatment was            time, while lower initial ISQ values increased more
IC




    signed by all patients prior to the study. Medical ex-        once osseointegration was stabilized (Tab. 5).
                                                                  Measurements of the distance from the implant shoul-
                                                                  der to the first bone to implant contact on periapical
    Table 1. Patient inclusion criteria.                          radiographs demonstrated a minimal crestal bone loss
C




                                                                  compared to the conventional titanium alloy dental im-
    Inclusion           Male or female at least 18 years of age
                                                                  plants (Tab. 5). PTTM manufacturing process is ex-
                        Benefit from the implant prosthesis
                                                                  tremely complex. It utilizes a chemical vapour deposi-
                        Insertion torque >35 Ncm
                                                                  tion process (CVD), which deposits elemental tanta-
    Exclusion           Subjects with bruxism or clenching
©




                                                                  lum (Ta) onto a substrate and therefore creates a na-
                         parafunctional habits                    notextured surface topography to build the Trabecular
                        Mental disorders                          Metal Material.
                        Uncontrolled systemic disease             Ta is a transitional metal often extracted from the min-
                        Untreated oral pathologies                eral tantalite, its atomic number is 73, it’s highly bio-
                        Pregnancy
                                                                  compatible and corrosion resistant (16). Ta is deposit-
                        Use of Bisphosphonates
                                                                  ed onto a vitreous carbon skeleton to reproduce the

    Annali di Stomatologia 2014; V (4): 136-141                                                                        137
    P. Papi et al.


    Table 2. Patient medical history.

    Patient          Diagnosis                 Treatment                      Implant placement                 Prosthetic Rehabilitation
    D.S.             Squamous cell             Anterolateral thigh flap       Six months later two              Six months later
    Woman            carcinoma of the right                                   submerged PTTM-dental             provisional acrylic resin




                                                                                                                        i
    52 year old      edge of the tongue                                       implants (4.1 x 10 mm)            fixed partial denture with




                                                                                                                      al
                                                                              in the right inferior canine      a distal cantilever for
                                                                              and premolar locations            second premolar
                                                                                                                occlusion. After one




                                                                                                                   on
                                                                                                                month temporization, a
                                                                                                                definitive ceramometal
                                                                                                                restoration
    L.T.             Unicystic ameloblastoma Radical resection of the         Six months later two              Five months later




                                                                                                         zi
    Woman            of the right mandibular right posterior mandible         submerged PTTM-dental             provisional fixed partial
    37 year old      quadrant                and simultaneous                 implants (4.1 x 10 mm,            denture, definitive
                                             reconstruction with iliac        4.1 x 11.5 mm) in the             ceramometal restoration
                                             crest flap                       right posterior mandible          one month later




                                                                                        na
    A.L.             Left floor-of-mouth       Partial mandibulectomy         One year after radiotherapy, Six months later
    Woman            cancer (FOM)              from the lower left second     seven submerged PTTM-        definitive, screw-retained
    74 year old                                premolar to the lower right    dental implants in the       prosthesis
                                               lateral incisor                mandible (2 each 4.1 x




                                                                             er
                                               END levels I-IV                10 mm, 2 each 4.1 x 11.5,
                                               Simultaneous anterolateral     two 4.7 x 11.5 mm and one
                                               thigh free flap                4.1 x 13 mm)
                                               Radiotherapy
    T.G.             Right FOM cancer          Segmental


                                                                t             One year after radiotherapy,      Tissue-supported
    Man
                                                             In
                                               mandibulectomy in the          four PTTM- dental implants        overdenture retained by
    56 year old                                right posterior mandible       were placed (2 each 4.1 x         ball abutments after 6
                                               Simultaneous pectoralis        10 mm and 2 each 4.7 x            months from implant
                                               major flap                     11.5 mm)                          placement
                                               Radiotherapy
                                               ni
    P.D.             Osteosarcoma of the       Partial maxillectomy           Seven months later six            Five months later fixed
    Man              jaw located in the        Simultaneous fibula free       submerged PTTM- dental            implant-supported
    45 year old      anterior region of        flap reconstruction            implants (3 each 4.1 x            prosthesis
                                      io


                     the maxilla                                              10 mm, 2 each 4.1 x
                                                                              11.5 mm, 1 each 4.7 x
                                                                              11.5 mm)
                             iz



    C.E.             Multicystic               Maxillectomy performed         Six months later four             Six months later a
    Woman            ameloblastoma of the      from the right canine to       PTTM- dental implants             bar-retained overdenture
    56 year old      upper jaw                 the second left molar          (2 each 4.1 x 10 mm,
          Ed




                                               Simultaneous fibula free       2 each 4.1 x 11.5 mm,
                                               flap reconstruction            4.7 x 11.5 mm)


    Table 3. Trabecular metal dental implants inserted.                   Table 4. Treatment sites.

    Lenghts (mm)              Diameters (mm) ø                            Maxillary locations                Lateral Incisor          1
IC




                              4,1 mm    4,7 mm         Implants                                              Canine                   1
                                                                                                             First premolar           1
    10 mm                     12           0           12
                                                                                                             Second premolar          1
    11,5 mm                   5            6           12
                                                                                                             First molar              6
    13 mm                     1            0           1
C




                                                                                                             Second molar             4
                                                                          Mandibular locations               Lateral Incisor          1
    trabecular bone structure and its properties. Prof.                                                      Canine                   5
    Branemark was the first to use Ta in the implantology                                                    First premolar           1
©




    field however due to its production costs and difficulty                                                 Second premolar          2
    of extraction it was quickly abandoned.                                                                  First molar              1
    Trabecular Metal material is a porous biomaterial with                                                   Second molar             1
    up to 80% interconnected porosity. It has an open-
    cell three-dimensional dodecahedrical shape, that re-                 of 440 μm to allow vascularized bone ingrowth, which
    sembles trabecular bone and its 12 interconnecting                    requires a minimum size of 300 μm (19).
    hexagonal pores. These pores have an average size                     PTTM enhanced titanium dental implants (Trabecular

    138                                                                                         Annali di Stomatologia 2014; V (4): 136-141
    Clinical evaluation with 18 months follow-up of new PTTM enhanced dental implants in maxillo-facial post-oncological
    patients




                                                                                                           i
                                                                                                         al
                                                                                                      on
                                                                                             zi
                                                                               na
    Figure 1. Trabecular metal dental implant.                    Figure 2. Trabecular metal dental implants placements.




                                                                     er
                                                                  Table 5. Resonance frequency Analysis (RFA).




                                                             t    Interval               ISQ Values                 Range
                                                          In      Surgery                72.14±5.61                 50-81
                                                                  2 Months               64.39±8.12                 44-74
                                                                  4 Months               74.26±7.14                 52-80
                                                                  6 Months               76.84±7.65                 60-83
                                                                  1 Year                 78.13±4.14                 64-84
                                                  ni
                                                                  18 Months              80.22±6.23                 68-89


    Figure 3. Post-surgical orthopantomography.
                                    io


    Table 6. Crestal bone loss (mm).
                           iz



    Interval                       Measurement Location               Mean Bone level (mm)                  Range
    Surgery                        Mesial                             0.5±0.48                              0.07-1.8
                                   Distal                             0.62±0.70                             0.03-2.3
           Ed




                                   Average                            0.56±0.48                             0.03-2.3
    2 Months                       Bone loss Mesial                   0.21±0.46                             -0.65-1.1
                                   Bone loss Distal                   0.18±0.23                             -0.48-0.94
                                   Bone loss Average                  0.19±0.25                             -0.48-1.1
    4 Months                       Bone loss Mesial                   0.24±0.48                             -0.9-1.4
                                   Bone loss Distal                   0.20±0.22                             -0.8-1.5
IC




                                   Bone loss Average                  0.22±0.4                              -0.8-1.5
    6 Months                       Bone loss Mesial                   0.28±0.49                             -1.06-1.2
                                   Bone loss Distal                   0.33±0.48                             -0.8-0.96
                                   Bone loss Average                  0.3±0.46                              -0.8-1.2
C




    1 Year                         Bone loss Mesial                   0.55±0.71                             -0.78-2.09
                                   Bone loss Distal                   0.59±0.53                             -0.41-1.89
                                   Bone loss Average                  0.57±0.62                             -0.78-2.09
©




    18 Months                      Bone loss Mesial                   0.62±0.73                             -0.84-2.20
                                   Bone loss Distal                   0.66±0.52                             -0.70-1.99
                                   Bone loss Average                  0.64±0.60                             -0.70-2.20

    Metal Dental Implant, Zimmer Dental Inc., Carlsbad,           nium multi threaded self-tapping endosseous dental
    CA, USA) were introduced in 2012. They are com-               implant (Tapered Screw-Vent Implant, Zimmer Dental
    posed of a PTTM material midsection added to a tita-          Inc., Carlsbad, CA, USA). These dental implants con-

    Annali di Stomatologia 2014; V (4): 136-141                                                                            139
    P. Papi et al.


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    Annali di Stomatologia 2014; V (4): 136-141                                                                                      141
