Clinical Trial: mp3 vs Apatos in Post-extractive Sockets

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Randomized-controlled Multicenter Clinical and Histological Study of Extraction Site Augmentation With mp3 vs. Apatos

Brief Summary:

The primary aim of the present multicenter randomized controlled trial was to evaluate and compare the shortterm clinical and histological changes of extraction sockets after ridge preservation procedures with changes of extraction sockets that healed naturally.

The secondary aim was to evaluate which, if any extraction socket characteristics could have affected tissue changes occurring at the augmented as well as naturally healed sites.

Recruitment and enrollment of patients were performed from June 2011 to June 2012 in five university centers/private practice:

  • University of Pisa;
  • University of Murcia;
  • University of Ancona;
  • Private practice, Dr. Di Felice;
  • University of Verona.

Randomization:

  1. extraction sockets with spontaneous healing;
  2. extraction sockets grafted with pre-hydrated collagenated cortico-cancellous porcine bone, with a particle size between 600 and 1000 μm;
  3. extraction sockets grafted with cortical porcine bone, with a particle size between 600 and 1000 μm.

Outcome Variables

  • Complications
  • Changes of ridge volume contour;
  • Vertical bone changes;
  • Buccal-Lingual Width;
  • Histomorphometric parameters.

    • Detailed Summary:

    BACKGROUND

    Following tooth extraction, the alveolar ridge undergoes a marked change. During the first year after tooth extraction, about 50% of the bucco-lingual ridge dimension will be lost. Furthermore, ridge reduction will become more pronounced from a buccal than from a lingual/palatal aspect. The hard tissue modelling and remodelling following tooth extraction were studied in the dog model. It was demonstrated that the socket was first occupied by a coagulum that was replaced with granulation tissue, provisional connective tissue and woven bone. This immature hard tissue was subsequently replaced with lamellar bone and bone marrow. During the healing phase, the height of the buccal bone wall was substantially reduced. In addition, about 30% of the marginal portion of the alveolar process of the extraction site was lost.

    Several approaches have been tested to preserve or improve the dimension and contour of the ridge following tooth extraction including the use of various graft or filler materials such as autografts, allografts, xenografts and/ or barrier membranes. The most recent studies on animals as well as in humans showed that the placement of xenografts in fresh extraction sockets promoted de novo hard tissue formation, in particular in the marginal portion of the extraction site. Moreover, it should be considered that the dimension of hard tissue walls was maintained and the profile of the ridge preserved. The data concerning socket preservation techniques in humans are still scarce. Therefore, firm conclusions about dimensional changes cannot be drawn currently; in reality, socket preservation procedures may aid in reducing the bone dimensional changes following tooth extraction. However, they do not completely prevent bone resorption so that a loss in width and height may be still expected; even if this proce
    Sponsor: Tuscan Dental Institute

    Current Primary Outcome:

    • Vertical bone changes [ Time Frame: 0, 1, 3, 12, 24, 36 months after grafting ]
      Vertical bone changes were evaluated in mm with the use of a custom made stent at mesial, distal, buccal and lingual/palatal sites; it was set as the distance between the reference point and the most apical point of the marginal bone level. Changes at the vertical bone level were evaluated by subtracting the postoperative value from the respective baseline value.
    • Volume of the alveolar ridge [ Time Frame: 0, 1, 3, 12, 24, 36 months after grafting ]
      Several impressions of the experimental sites were obtained from each patient. Impressions of the jaw were obtained in a one-step process with two viscosity polyvinyl siloxane impression materials. Within 24 h, model casts of the dental impressions were obtained using plaster of Paris. A scanner for cone-beam computerized tomography was employed for 3D file acquisition of the different model casts of each patient. The CBCT scan data were inserted into a Matrix Laboratory, and for each patient, positions of axial images related to all time frames were elaborated in space in such a way that the residual teeth were superimposable (Sbordone et al. 2012a,b); A volumetric evaluation (V in cm3) of the study models in the site subjected to alveolar ridge preservation was performed with Segment and Planning tool of SimPlant Pro 12.02.
    • Buccal-Lingual Width [ Time Frame: 0, 1, 3, 12, 24, 36 months after grafting ]
      Buccal-Lingual Width was evaluated in mm, measuring the distance between buccal and lingual/palatal plate with a periodontal probe. Changes at bucco-lingual width were calculated by subtracting the baseli

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • NFB: newly formed bone [ Time Frame: 3 months after extraction procedure ]
        Specimens were decalcified in ethylenediaminetetraacetic acid (10%) for a period of 2 weeks. Specimens were again X-rayed in order to verify the decalcification procedure. After dehydratation in graded series of ethanol, the specimens were embedded in paraffin, sectioned (3-5 μm sections), and stained with hematoxyline-eosine and modified Mallory aniline blue. Examinations were performed in a Nikon Eclipse 80i microscope≠≠ using X1.0 to X40 objectives for descriptive evaluation and morphometrical measurements. Histomorphometric measurements were performed in order to calculate the percentages (i.e., area fraction in %) of mineralized bone 3 months after extraction procedure. All measurements were determined by using an Easy image 2000 system≠≠ for area measurements. A mean value from 3 different areas was calculated giving percentages of the above.
      • RGP: residual graft particle [ Time Frame: 3 months after extraction procedure ]
        Specimens were decalcified in ethylenediaminetetraacetic acid (10%) for a period of 2 weeks. Specimens were again X-rayed in order to verify the decalcification procedure. After dehydratation in graded series of ethanol, the specimens were embedded in paraffin, sectioned (3-5 μm sections), and stained with hematoxyline-eosine and modified Mallory aniline blue. Examinations were performed in a Nikon Eclipse 80i microscope≠≠ using X1.0 to X40 objectives for descriptive evaluation and morphometrical measurements. Histomorphometric measurements were performed in order to calculate the percentages (i.e., area fraction in %) of residual graft materials 3 months after extraction procedure. All measurements were determined by using an Easy image 2000 system≠≠ for area measurements. A mean value from 3 different areas was calculated giving percentages of the above.
      • NMT: non-mineralized tissue [ Time Frame: 3 months after extraction procedure ]
        Specimens were decalcified in ethylenediaminetetraacetic acid (10%) for a period of 2 weeks. Specimens were again X-rayed in order to verify the decalcification procedure. After dehydratation in graded series of ethanol, the specimens were embedded in paraffin, sectioned (3-5 μm sections), and stained with hematoxyline-eosine and modified Mallory aniline blue. Examinations were performed in a Nikon Eclipse 80i microscope≠≠ using X1.0 to X40 objectives for descriptive evaluation and morphometrical measurements. Histomorphometric measurements were performed in order to calculate the percentages (i.e., area fraction in %) of non-mineralized tissue (i.e., connective tissue and/or bone marrow) 3 months after extraction procedure. All measurements were determined by using an Easy image 2000 system≠≠ for area measurements. A mean value from 3 different areas was calculated giving percentages of the above.


      Original Secondary Outcome: Same as current

      Information By: Tuscan Dental Institute

      Dates:
      Date Received: December 22, 2015
      Date Started: June 2011
      Date Completion:
      Last Updated: December 28, 2015
      Last Verified: December 2015