10.59987/ads/2018.4.162-166
The healing of a post-extraction socket and the final remodeling of the residual ridge represent a moment of fundamental importance in the study of bone regeneration and in the assessment all the methods to be implemented in order to guide this process in a profitable way. The purpose of this clinical evaluation is therefore to assess the effectiveness of a granular bovine bone (RE-BONE bone substitute, Ubgen System, Vigonza-PD, Italy) in promoting the formation of new bone and preserving the volume of the pre-existing one at the extraction site. 30 patients were involved in this study, involving a total of 30 alveolar sockets treated with new medical devices. Each patient was treated 4g of bovine bone in granular form. Our pilot study, carried out on the samples considered suitable by the operator, identified the presence or absence of mineralized bone, soft tissue and graft material, through a qualitative and quantitative percentage assessment. The results showed an optimal percentage of new bone formation, with a prevalence of hard tissue. The presence of grafting material constituted only a small percentage in most of the analyzed samples, demonstrating that the substituted material was optimally resorbed and replaced with new mature bone tissue.
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L. Signorini
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Annali di stomatologia
Implantology
Bone regeneration/repairing with an innovative bone substitute
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Original Article
2022-08-09
2022-08-09
2018-12-01
2023-12-04
162-166
Ann Stomatol (Roma)
L. Signorini
2018
10.59987/ads/2018.4.162-166
162
School of Dentistry, Saint Camillus University of Health Science, 00198 Rome, Italy
1971-1441
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Implantology
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Bone regeneration/repairing with an innovative bone substitute
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                                                                                                      Original article


Bone regeneration/repairing with an innovative
bone substitute


Antonio Scarano1                                               of fundamental importance in the study of bone regen-
Francesco Inchingolo2                                          eration and in the assessment of all the methods to be
Gianna Dipalma2                                                implemented, in order to guide this process in a profit-
Maura Boggian3                                                 able way.
Luca Signorini4                                                Following the loss of the tooth, in fact, various events
                                                               take place and lead to a variable amount of bone re-
1
    Department of Innovative Technologies in Medicine          sorption due to the qualitative and quantitative changes
    and Dentistry, University of Chieti-Pescara, 66100         that occur in the alveolar bone itself, around the ex-
    Chieti, Italy.                                             traction site (the alveolar process and more generally
2
    Department of Interdisciplinary Medicine, University of    the bone). Alveolar tooth-dependent structure (1) un-
    Medicine Aldo Moro, 70124 Bari, Italy.                     dergoes remodeling that is definitely characterized by
3
    Scientific Consultant, Ubgen Research Unit                 a marked reabsorption. Chronologically, during the first
4
    School of Dentistry, Saint Camillus University of Health   year following tooth extraction, large portions of cortical
    Science, 00198 Rome, Italy.                                bone are replaced with trabecular and medullary bone
                                                               (2-4) and there is a marked reduction in the size of the
Corresponding:                                                 extraction site both in the apico-coronal and in the buc-
Prof. Luca Signorini                                           co-lingual direction. In particular, some data are high-
                                                               lighted in the literature: after the first six months there
                                                               is a reduction of about 30% of the vestibular volume of
Abstract                                                       the residual alveolar ridge, but at the same time, new
                                                               bone is formed which fills the post-extraction defect. In
The healing of a post-extraction socket and the final
                                                               a radiographic study Tan et al. (2012) quantified the re-
remodeling of the residual ridge represent a moment
                                                               absorption, this was about 1.24mm vertically and 3.8
of fundamental importance in the study of bone re-
                                                               mm horizontally, 6 months after the extraction. Some
generation and in the assessment all the methods
                                                               authors have pointed out that bone loss is more marked
to be implemented in order to guide this process in
                                                               on the buccal side and leads to a shift of the alveolar
a profitable way. The purpose of this clinical eval-
                                                               ridge 2/3 lingually/palatally compared to the original po-
uation is therefore to assess the effectiveness of a           sition. In order to delay the processes of modification
granular bovine bone (RE-BONE bone substitute,                 of the alveolar ridge (horizontally and vertically) and of
Ubgen System, Vigonza-PD, Italy) in promoting the              volumetric reduction, that begin at the same time as the
formation of new bone and preserving the volume                healing process due to dental extraction, it is consid-
of the pre-existing one at the extraction site. 30 pa-         ered appropriate to preserve the post-extraction alve-
tients were involved in this study, involving a total          olus to allow a subsequent implant-prosthetic rehabili-
of 30 alveolar sockets treated with new medical de-            tation (4-7). To date, there are various techniques that
vices. Each patient was treated 4g of bovine bone              preserve the post-extraction socket. These employ the
in granular form. Our pilot study, carried out on the          use of grafting materials (or biomaterials) with or without
samples considered suitable by the operator, iden-             the association with biological membranes.
tified the presence or absence of mineralized bone,            The purpose of this clinical evaluation is therefore to as-
soft tissue and graft material, through a qualitative          sess the effectiveness of a granular bovine bone (RE-
and quantitative percentage assessment.                        BONE bone substitute, Ubgen System, Vigonza-PD,
The results showed an optimal percentage of new                Italy) in promoting the formation of new bone and pre-
bone formation, with a prevalence of hard tissue. The          serving the volume of bone at the extraction site.
presence of grafting material constituted only a small
percentage in most of the analyzed samples, demon-             Materials and Methods
strating that the substituted material was optimally
resorbed and replaced with new mature bone tissue.             All medical devices used in this study are approved for
                                                               commercial use and are freely provided by UBGEN, to
                                                               carry on the aims of this study. The supply of materials
Keywords: Dental Implants; Implantology
                                                               has been stored in an appropriate and safe place, and
Introduction                                                   is accessible only to people authorized to carry out this
                                                               protocol. Medical devices are:
The healing of a post-extraction socket and the final          - BMrebone01B (0,5g – 0,25-1 mm)
remodeling of the residual ridge represents a moment           - BMrebone01C (1g – 0,25-1 mm)

Annali di Stomatologia 2018; IX (4): 162-166                                                                                 162
      Bone regeneration/repairing with an innovative bone substitute

      Patient sample size                                              a fragment of Condress Collagen on suture with horizon-
      30 patients were involved in this study, involving a to-         tal “U” or “8” (silk 4-0). Finally, 600 mg of ibuprofen was
      tal of 30 alveolar sockets treated with the new medical          given every 8 hours, as needed, on a full stomach.
      devices. Each patient was treated 4g of bovine bone in
      granular form in the following quantities:                       Visit 3 - Suture Removal.
      • BMrebone01B (0,5g - 0,25-1 mm)                                 Removed the sutures after 12 days.
      • BMrebone01C (1g - 0.25-1 mm)
                                                                       Visit 4 - Check-up at 30 days
      Criteria for admission to the study                              The check has been performed.

      Inclusion criteria                                               Visit 5 - Checkup at 60 days
      Patients involved in the study, and which therefore re-          The check has been performed.
      sponded to the inclusion criteria, were aged between
      20 and 70 years with one or more teeth to be extracted           Visit 6 - Checkup at 90 days
      and substituted with implants. Those presented a med-            The check has been performed.
      ical history without significant pathologies and were not
      using drugs that could condition the bone metabolism.            Visit 7 - Check-up at 120 days
      These are healthy subjects, at most, with the presence           The patient underwent antibiotic coverage (Amoxicillin
      of compensated arterial hypertension and / or compen-            Clavulanate 1000 mg: 1 tablet every 8 hours for 7 days
      sated hypercholesterolemia. The patients selected in             before intake, 1 tablet 3 hours before surgery).
      the study presented post-extraction sockets with buc-            Infiltration anesthesia (Articaine with 1/100K vasocon-
      cal wall and the simultaneous presence of upper pre-             strictor) was administered on site. Bone biopsy was per-
      molars with chronic periapical pathologies refractory to         formed with a drill (internal diameter 2 mm) and subse-
      orthograde orthodontic treatment and / or with reduced           quent implant placement. Finally, the site was sutured.
      coronal support.
      Because of the impossibility to find cases with premolars        Visit 8– after 4/5 months prosthetic finalization
      to be extracted, subjects with upper incisors and canines        The check has been performed.
      to be removed were also included in the study for the
      aforementioned reasons.                                          Biopsy
                                                                       Samples until processing were stored by neutral buff-
      Exclusion criteria                                               ered formalin fixation process in a dark glass bottle and
      Smoking patients, pregnant women, patients with chron-           bakelite cap.
      ic systemic diseases (e.g. diabetes) and neoplastic of
      the facial district, patients using bisphosphate were ex-        Fixation
      cluded from the study. Equally, all those subjects who           The sample was fixed in neutral buffered formalin and
      presented any sites already implant failure localized, un-       placed in the glass bottle with stopper provided at the
      treated periodontitis, sites with acute infections, chronic      start of the clinical trial.
      inflammatory diseases of the oral cavity. Finally, subjects
      with autoimmune diseases (taking cortisone), declared            Identification
      allergy to one or more medications to be used during             An identification tag was placed on each bottle with the
      treatment and finally alcoholics and /or drug addicts            patient identification code.
      were also excluded.
                                                                       Processing
      Plan of the study                                                The biopsy samples were dehydrated in order to include
      The study plan was divided into eight visits.                    them in paraffin to obtain sections prepared on special
                                                                       slides subjected to staining with hematoxylin-eosin.
      Visit 1 - Pre-surgical evaluation
      Patients were evaluated according to the inclusion and           Histological and histomorphometric analysis
      exclusion criteria. To start the recruitment, informed con-      In order to carry out histological and histomorphomet-
      sent was signed, and an identification code was gener-           ric analysis, the various samples taken were analyzed
      ated and assigned for each patient.                              and photographed, at various magnifications; an optical
                                                                       microscope, with digital image reconstruction, with a
      Visit 2 - Extraction and filling of the site with bone sub-      transmitted and polarized illumination, was used. In the
      stitute REBONE                                                   various sections, the tissues and materials present, such
      The patient underwent antibiotic coverage with Amoxicil-         as mineralized bone, medulla and grafting material, were
      lin Clavulanate 1000 mg: 1 tablet every 8 hours for 7 days       identified. Therefore, we proceeded with the qualitative
      before intake, 1 tablet 3 hours before surgery. Infiltration     and quantitative evaluation of each sample with dedi-
      anesthesia was administered on site (Articaine with 1 /          cated software and finally, the data were analyzed for
      100K vasoconstrictor) and an extraction as atraumatic            statistical purposes.
      as possible (odontotomy) was performed. The sockets
                                                                       Results
      were cleaned, the granulation tissue was removed and
      a local bleeding was stimulated. The site was filled with        Our pilot study, carried out on the samples considered
      RE-BONE® pre-hydrated with sterile physiological solu-           suitable by the operator, identified the presence or ab-
      tion (without overfilling), the graft was then covered with      sence of mineralized bone, soft tissue and graft mate-

163                                                                                       Annali di Stomatologia 2018; IX (4): 162-166
A. Scarano et al.

rial, through a qualitative and quantitative percentage      Also, the clinical findings showed how the healing of the
assessment (Table1). The results showed an optimal           sockets treated with RE-BONE at the initial time (T0) and
percentage of new bone formation, with a prevalence          at a control time (after 120 days) was excellent locally
of hard tissue. The presence of grafting material con-       and macroscopically (Figg. 2, 3).
stituted only a small percentage in most of the analyz-      The samples taken from the biopsy were dehydrated,
ed samples, demonstrating that the substituted material      embedded in paraffin to obtain sections, stained with
was optimally resorbed and replaced with new mature          hematoxylin-eosin, prepared on special slides. The sam-
bone tissue (Fig. 1).                                        ples were photographed and analyzed accordingly at
                                                             various magnifications; an optical microscope, with dig-
Table 1.                                                     ital image reconstruction, with a transmitted and polar-
  Histological samples of post-extraction alveolar           ized illumination, was used. The results show that after
            bone treated with RE-BONE                        30 days (Figure 3) an intense osteogenic activity was
                                                             present. The bone was immature but already present
                  Bone (%)     Soft tissue (%)   Graft (%)   to ensure clinical support. After 90 days (Figure 4) the
  Sample 1          20.87           25.33         53.80      mineralization was almost completed and the bone had
                                                             replaced most part of REBONE material.
  Sample 2          68.76            3.30         27.95
  Sample 3          15.27           50.39         34.34
                                                             Discussion
  Sample 4                                                   Regenerative medicine is a discipline aimed at tissue
                    45.87           31.61         22.64
                                                             regeneration that uses external means to improve or re-
  Sample 5          48.99           10.46         40.66      store the natural healing capacity of our body. Immedi-
                                                             ate implant placement does not prevent the resorption
  Sample 6          30.30           22.75         46.95
                                                             of the buccal bone crest (1) and several oral tissues
  Sample 7          54.49           12.42         33.08      may have more difficulties in triggering their own repair
                                                             mechanisms. These situations are hampered by condi-
  Sample 8            0             39.43         60.57      tions such as: the absence of oxygen and nutrients, a
  Sample 9          24.58           20.59         54.83      chronic inflammatory state, a particularly complex tis-
                                                             sue matrix to remodel. From a clinical point of view, the
  Sample 10         30.30           22.75         46.95      preservation of the ridge and the socket often needs a
  Sample 11         22.41           19.32         58.27      bone tissue graft for the proper management of defects
                                                             in the buccal bone before insertion of implants (2). The




Figure 1.

Annali di Stomatologia 2018; IX (4): 162-166                                                                             164
      Bone regeneration/repairing with an innovative bone substitute


       A




       B




      Figure 2. A. (T0). B. After 120 days.




      Figure 3. After 30 days.                                     Figure 4. After 60 days.

165                                                                                    Annali di Stomatologia 2018; IX (4): 162-166
A. Scarano et al.

REBONE bone substitute, thanks to the high surface/                      immediate implant placement and ridge preservation tech-
volume ratio, is an ideal scaffold for osseointegration                  niques: review of morphometric studies in animals. Implant
and osteoinduction, furthermore, the highly porous and                   Dent 2013,22,155-160.
                                                                    2.   Wang, R.E.; Lang, N.P. Ridge preservation after tooth ex-
interconnected structure carries out an osteoconductive                  traction. Clin Oral Implants Res 2012,23,147-156.
action capable of promoting cell colonization, the circu-           3.   Hämmerle, C.H.; Araújo, M.G.; Simion, M. Evidence-based
lation of substances nutrients and rapid vascularization.                knowledge on the biology and treatment of extraction sock-
After having carried out the function of filling, support                ets. Clin Oral Implants Res 2012,23,80-82.
and osteoconduction, the bone substitutes used in this              4.   Darby, I.; Chen, S.T.; Buser, D. Ridge pres-ervation tech-
study are completely degraded by osteoclastic activity                   niques for implant therapy. Int J Oral Maxillofac Implants
                                                                         2009,24,260–271.
and physiologically remodeled into new vital bone tis-              5.   Barone, A.; Ricci, M.; Calvo-Guirado, J.L.; Covani, U. Bone
sue already after 60 days.                                               remodelling after regen-erative procedures around implants
                                                                         placed in fresh extraction sockets: an experimental study in
                                                                         Beagle dogs. Clin Oral Implants Res 2011, 22,1131–1137.
Conflicts of Interest: “The authors declare no conflict             6.   Feller, L.; Khammissa, R.A.; Bouckaert, M.; Lemmer, J. Al-
of interest.”                                                            veolar ridge preservation immediately after tooth extraction.
                                                                         SADJ 2013,68,408-410.
                                                                    7.   Sbordone, L.; Levin, L.; Guidetti, F.; Sbordone, C.; Glikman,
                                                                         A.; Schwartz-Arad, D. Apical and marginal bone alterations
References                                                               around implants in maxillary sinus augmentation grafted
1.   Viña-Almunia, J.; Candel-Martí, M.E.; Cervera-Ballester, J.;        with autogenous bone or bovine bone material and simul-
     García-Mira, B.; Calvo-Guirado, J.L.; Peñarrocha-Oltra, D.;         taneous or delayed dental implant positioning. Clin Oral Im-
     Peñarrocha-Diago, M. Buccal bone crest dynamics after               plants Res 2011,22, 485–491.




Annali di Stomatologia 2018; IX (4): 162-166                                                                                             166
