Comparison Using Pericardial Membrane Versus Titanium Mesh" in Horizontal Alveolar Ridge Augmentation
Condition: Horizontal Ridge Augmentation, Histological and Clinical Result
Study type: Interventional

Summary: 
      Randomized clinical trial study ,The purpose of this study To evaluate the potential
      application of resorbable pericardium to augment localized alveolar ridge defects in esthetic
      zone, from histological, radiographical and clinical aspects in comparison with titanium mish
      for the subsequent placement of dental implants Reconstruction of alveolar bone defect can be
      achieved through many regenerative surgical procedures including guided bone regeneration
      (GBR).Tenting of the periosteum using a cortical bone block maintains space and minimizes
      resorption of the particulate graft volume
    

Detailed description: 
      Randomized clinical trial study ,The purpose of this study To evaluate the potential
      application of resorbable pericardium to augment localized alveolar ridge defects in esthetic
      zone, from histological, radiographical and clinical aspects in comparison with titanium mish
      for the subsequent placement of dental implants Reconstruction of alveolar bone defect can be
      achieved through many regenerative surgical .

      Patient selection:

      20 patients will be selected from the outpatient clinic of the department of, Oral medicine
      and Periodontology, Faculty of Dentistry, Ain Shams University.

      Patient grouping and treatment protocol The purpose of this study is to evaluate the results
      of alveolar ridge augmentation using two types of guided membranes.

      Patients will be randomly divided into two groups according to the type of membrane will used
      in alveolar ridge augmentation.

      All the patient's records will be coded, known only by the researcher for the purpose of
      confidentiality.

      Every patient participating in this study will sign an informed consent demonstrating the
      purpose of this study, surgical procedure, probable risks and benefits from this surgical
      intervention.

      In case of failure, the patient will be compensated with the suitable ordinary either fixed
      or removable prosthesis. Every patient could quit at anytime without penalty or loss of any
      benefits. The faculty research ethics committee will review the proposal.

      Eligible patients will be randomized in a 1:1 ratio into two groups; (Group I) included 10
      patients and (Group II) included 10 patients. The computer-generated randomization assignment
      (blocks of 4) and allocation concealment will be performed by sealed envelopes containing the
      randomization number prepared by non involved member and sent to principle investigator to
      assign the interventions to patients.

      Group 1:

      Will include 10 patients and alveolar ridge augmentation will be performed using intraoral
      autogenous block bone graft in addition to particulate xenograft to fill discrepancies
      covered by titanium mesh .

      Group 2 Will include 10 patients and alveolar ridge augmentation will be performed using
      intraoral autogenous block bone grafting addition to particulate xenograft to fill
      discrepancies covered by pericardial membrane.

      Patients may suffer postoperatively from pain, edema, infection which will be controlled by
      antibiotics and anti-inflammatory and proper oral hygiene measures with chlorhexidine mouth
      wash.

      Risks of failure will be minimized as much as possible by proper patient selection, properly
      prepared surgical protocol, and rapid placement of the graft after harvesting to avoid viable
      cells death, short surgeries as much as possible, strict aseptic techniques, proper infection
      control measures, proper home oral hygiene measures and regular follow ups for maintenance of
      the oral hygiene.

      Measurements and evaluation of edentulous ridge

        -  Preoperative evaluation will be performed for all patients at baseline. This evaluation
           will include Cone Beam Computed Tomography (CBCT) using standardized and clinical
           photographs using UNC periodontal probe .

        -  Two different techniques will be used to measure the alveolar ridge labiolingual width
           before and after ridge augmentation:

             1. Cone Beam Computed Tomography (CBCT)

      This will be carried out at 2 intervals:

        1. Baseline CBCT will be performed before the first surgery.

        2. The second CBCT will be performed before the second surgery.

      The Ridge measurement technique will standardized by using vacuum form acetate stent (0.4 mm
      base plate thermoforming material). references points placed on palatine surface using
      gutta-percha point .t this point sagittal section of the ridge has taken on CBCT software
      ,same stent used during 2nd cone beam after 4 months and take a sagittal section cut at level
      of same gutta percha point : at same sagittal cut which taken at pre and post operative cone
      beam measuring a horizontal Bucco -lingual line width on 3 points occlusal-apical .

      2-UNC 15-color coded probe

        1. at first surgery; done on the bony ridge directly after mucoperiosteal flap elevation
           before bone graft placement.

        2. During the second surgery (re-entry surgery for implant placement) after 4 months; it
           will be done on the bony ridge with the mucoperiosteal flap elevation.

           .

           Evaluation of the Augmented Bone Quality:

           After 4 month re-entry for implant placement and histological evaluation of the grafted
           bone should be performed.

           Preoperative preparation:

           The surgical procedures were performed under local anesthesia of
           Articainchlorhydrate1:100000.

           Pre-operative rinsing of the oral cavity with a 0.2% chlorhexidine and a perioral skin
           disinfection with Betadine antiseptic solution. An antibiotic therapy 1 h before surgery
           will administrated to the patient, with 2 g of amoxicillin clavulanate (Augmentin)

           Incision and preparation of recipient site:

           A mid-crestal horizontal incision will be made with oblique releasing incisions where
           needed in order to mobilize a full-thickness flap.

           The flap will carefully be elevated from the palatal and buccal aspect of the alveolar
           ridge.

           All the granulation tissue will be removed from the cortical bone. The intra-surgical
           evaluation confirmed a narrow alveolar ridge with insufficient crest width for ideal
           dental implant placement gauged by using UNC 15-color coded periodontal probe or bone
           caliber caliper to identify and measure the greatest horizontal alveolar ridge defect.

           Intra-surgical evaluation confirmed a narrow alveolar ridge with insufficient crest
           width for ideal dental implant placement

           Perforations into the marrow space will performed using small round surgical burs to
           facilitate vascularization of the graft and cell colonization from the bone marrow.

           Bone graft From Donor site:

           For both groups:

             -  Sub-marginal attached gingival incision will be used for papilla preservation

             -  The intraoral autogenous block graft will be harvested from the mandible symphyses
                using trephine burs.

             -  The donor site will be examined clinically and radiographically, it should be
                easily accessible, with no apparent infection or anatomical abnormality .

           In cases Guided Bone Regeneration with Titanium mesh ( Ti-mesh):

             -  A 0.2 mm thickness Ti-mesh will be trimmed and adapted to the surgical defect to
                create a proper bone contour.

             -  The Ti-mesh should be shaped avoiding sharp edges in order to prevent soft tissue
                dehiscence or exposure.

             -  The minimum distance from the periodontium of the neighboring teeth was 1.5 mm in
                order to prevent possible infiltrations through the gingival sulcus

             -  The defects will be filled with autogenous bone block, bone chips mixed with
                xenograft , so that the deficiencies completely filled, this will recreate the
                ideal amount of bone for subsequent implant placement.

             -  The Ti-mesh then placed over the graft and fixed to the palatal and buccal bony
                walls using cortical screws on each side to prevent any micro movement.

             -  Periosteal incisions on the flaps will be performed in order to promote a
                tension-free closure and to mobilize the buccal flap and obtain the passive closure
                essential to prevent dehiscence and Ti-mesh exposure.The releasing incisions should
                be placed 3 to 4 mm in length at the apical extent of the vertical releasing
                incision (in the buccal vestibule), which directed away from the vertical incisions
                created a split-thickness flap past the mucogingival line as they proceeded
                apically to release the flap

             -  Double layer suture should be applied with horizontal mattress and circumferential
                interrupted suture using a suture 5-0 polypropylene suture, to seal the overlapping
                periosteal portion of the palatal and buccal flap.

           In cases of Guided Bone Regeneration using pericardium membrane with tenting screw:

             -  The augmentation technique will used in both treatment groups is the same, with the
                exception of the membrane material.

             -  1.4-mm-diameter titanium reference screw will be placed perpendicular to the
                alveolar ridge, extending laterally to the desired amount of horizontal
                augmentation and fixed the autologous bone block which act as tenting with titanium
                screw.

             -  The attempted horizontal gain will be measured, from the screw head to the bone
                using a UNC-15 periodontal probe.

           The particulate graft consisted of a combination of xenograft and particulate autogenous
           bone then applied to the recipient site using a bilayer technique with the autogenous
           particles placed against the native bone.

             -  The particulate bone graft will be placed around supporting tenting screws to the
                level of the screw heads and covered with a pericardium membrane, which will be
                fixed to the bone with titanium tacks.

             -  Primary closure should be obtained by using a combination of interrupted and
                horizontal mattress sutures using 5-0 polypropylene sutures, to seal the
                overlapping periosteal portion of the palatal and buccal flaps.

           Post-operative Medication and follow up:

             -  1 g of Augmentin twice a day for 7 days, 500mg metronidazole twice a day for 7
                days, a 0.2% Chlorhexidine gluconate (mouthwash rinse solution 1min three times a
                day for the same period of time, starting the day after the surgery and Brufen 600
                mg 3 times daily for 7 days as analgesic and anti inflammatory

             -  The sutures will be removed after 14 days.

             -  Follow up phase: 7 days after 1st surgery, fourteen days after the sutures will be
                removed then the patient will be instructed to return for follow-up visits every 2
                weeks for the first month then once monthly until re-entry surgery. At the follow
                up visits both recipient and donor sites will be clinically examined for soft
                tissue healing .

             -  After 4 months The second radiographic evaluation of alveolar ridge width by Cone
                Beam Computed Tomography (CBCT) will be performed before the second surgery.

                2nd surgical stage

             -  Fixation and tenting screws which had been used to stabilize the graft during
                healing will be removed and retrieve the Titanium mesh.

             -  A bone biopsy will be harvesting from the grafted area using trephine bur will
                obtained prior to implant placement for histological evaluation.

             -  Implant placement.

             -  All the patients will receive supra-structure prosthetic part .

           Statistical Analysis:

           All the clinical, Radiographical , Histomorphometric data will be tabulated and the
           result will be subjected to statistical analysis.
    

Intervention name(s): horizontal alveolar ridge augmentation
Intervention type(s): Procedure
Intervention description(s): evaluate the potential application of resorbable pericardium membrane to augment localized alveolar ridge defects in esthetic zone, from histological, radiographical and clinical aspects in comparison with titanium mish for the subsequent placement of dental implants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present randomized clinical study was conducted to assess histological, histomorphometric, radiographic and the clinical response of bone after 4 months of augmentation and to compare the amount of horizontal bone gained between both groups and compare the quality of gained bone using a native pericardium physical resorbable barrier made of bovine pericardium with 1:1 mixture of bone graft in test group versus using titanium mesh with 1:1 mixture of bone graft in control group to augment localized horizontal alveolar ridge defects for the subsequent placement of dental implants.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment