<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839615</url>
  </required_header>
  <id_info>
    <org_study_id>GBR using ptfe vs collagen</org_study_id>
    <nct_id>NCT03839615</nct_id>
  </id_info>
  <brief_title>Poly Tetra Fluro Ethylene vs Native Collagen Membrane for Gbr in Anterior Maxilla</brief_title>
  <official_title>Assessment Of Poly Tetra Fluro Ethylene Membrane Versus Native Collagen Membrane With Guided Bone Regeneration In Atrophic Anterior Maxilla Using (1:1) Of Autogenous Bone And Xenograft Mixture (Randomized Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe&#xD;
      membrane while using a 1:1 mix of xenograft and autogenous bone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The alveolar bone is formed during tooth eruption, and consists of maxillary and mandibular&#xD;
      components that shape and support the alveolar sockets. When teeth are lost, alveolar atrophy&#xD;
      occurs, ultimately resulting in a short and narrow alveolar ridge . Such changes in the&#xD;
      alveolar bone have a significant effect on prosthetic restoration planning, and are&#xD;
      particularly important for areas with esthetic requirements, such as the maxillary incisors.&#xD;
      Since preservation of the alveolar bone after extraction makes implant placement and&#xD;
      prosthetic restoration easier in the edentulous jaw, alveolar ridge preservation and&#xD;
      reconstruction methods using various bone graft materials together with resorbable and&#xD;
      non-resorbable membranes have been introduced in order to minimize the loss of alveolar bone&#xD;
      after extraction.&#xD;
&#xD;
      Investigations of changes in the alveolar bone after extraction have frequently been&#xD;
      performed through clinical measurements and radiographic analysis. In particular, after the&#xD;
      extraction of a tooth with fracture or severe periodontitis, the alveolar bone shows severe&#xD;
      horizontal and vertical atrophy. The reduction in the width of the alveolar ridge is more&#xD;
      notable in the horizontal direction than in the vertical direction, and the buccal wall of&#xD;
      the alveolar bone has been reported to undergo greater vertical atrophy than the lingual&#xD;
      wall. Changes in the width of the alveolar ridge after extraction occur in a relatively short&#xD;
      time, decreasing most rapidly within the first six months after extraction, followed by&#xD;
      continual, slow bone resorption over the course of the rest of the patient's life .&#xD;
&#xD;
      When a tooth has been lost, the extent of alveolar bone resorption is affected by a range of&#xD;
      factors, including the number of extracted teeth and bone walls, the bone density, the extent&#xD;
      of alveolar bone loss, infection, and the presence or absence of adjacent teeth.&#xD;
&#xD;
      Dental implant has become a predictable treatment option, with excellent long-term results.&#xD;
      However, the success of implant therapy depends on the amount of bone volume at the insertion&#xD;
      site.Unfavorable local conditions may provide insufficient bone volume that negatively&#xD;
      affects the prognosis of dental implants. Cawood and Howell in 1988 ranked the atrophy degree&#xD;
      of edentulous jaws in six classes. Particularly, atrophies within class IV, also known as&#xD;
      &quot;knife-edge&quot; ridges, present a serious horizontal defect, making challenging the placement of&#xD;
      regular implants.&#xD;
&#xD;
      Many techniques have been developed to regenerate atrophic alveolar jaws for the placement of&#xD;
      dental implants, performed either in combination with graft procedures or in second stage&#xD;
      surgery after a period of healing. For many years, bone blocks represented the gold standard&#xD;
      to reconstruct the alveolar ridge bone defects. This technique requires to harvest a wide&#xD;
      amount of bone to rebuild the atrophic crest.(20). For this reason, bone blocks were often&#xD;
      harvested from extra-oral sites with an higher morbidity. Moreover some problems can occur&#xD;
      when a combined defects (horizontal and vertical) need to be treated. Guided bone&#xD;
      regeneration (GBR) has been proposed as a possible alternative for patients with severe&#xD;
      horizontal bone atrophy, to overcome the drawback of bone blocks techniques. To protect and&#xD;
      prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological&#xD;
      space for the regeneration of bone tissue, the use of both non-resorbable or resorbable&#xD;
      membranes, in combination with autologous or heterologous particulate bone have been&#xD;
      proposed. Particulated autogenous bone can be mixed with bone substitutes to add more&#xD;
      osteogenic factors.&#xD;
&#xD;
      Guided bone regeneration or GBR, and guided tissue regeneration or GTR are dental surgical&#xD;
      procedures that use barrier membranes to direct the growth of new bone and gingival tissue at&#xD;
      sites with insufficient volumes or dimensions of bone or gingiva for proper function,&#xD;
      esthetics or prosthetic restoration.&#xD;
&#xD;
      GBR is similar to guided tissue regeneration (GTR) but is focused on development of hard&#xD;
      tissues in addition to the soft tissues of the periodontal attachment. At present, guided&#xD;
      bone regeneration is predominantly applied in the oral cavity to support new hard tissue&#xD;
      growth on an alveolar ridge to allow stable placement of dental implants.&#xD;
&#xD;
      The first application of barrier membranes in the mouth occurred in 1982. in the context of&#xD;
      regeneration of periodontal tissues via GTR, as an alternative to resective surgical&#xD;
      procedures to reduce pocket depths.Barrier membrane is utilized in GBR technique to cover the&#xD;
      bone defect and create a secluded space, which prevents the connective tissue from growing&#xD;
      into the space and facilitates the growth priority of bone tissue.&#xD;
&#xD;
      Several surgical techniques via GBR have been proposed regarding the tri-dimensional bone&#xD;
      reconstruction of the severely resorbed maxilla, using different types of bone substitutes&#xD;
      that have regenerative, osseoinductive or osseoconductive properties which is then packed&#xD;
      into the bony defect and covered by resorbable membranes. In cases where augmentation&#xD;
      materials used are autografts or allografts the bone density is quite low and resorption of&#xD;
      the grafted site in these cases can reach up to 30% of original volume. For higher&#xD;
      predictability, nonresorbable titanium-reinforced d-polytetrafluoroethylene (d-PTFE)&#xD;
      membranes-as a barrier against the migration of epithelial cells within the grafted site-are&#xD;
      recommended.&#xD;
&#xD;
      Non-resorbable membranes retain their shape and structure in the tissues, requiring a second&#xD;
      surgical procedure for removal, with consequent additional patient discomfort, and a raise in&#xD;
      the costs and duration of the therapy. Non-resorbable membranes include: (i) expanded&#xD;
      polytetrafluoroethylene (e-PTFE, Gore-Tex®); (ii) high-density polytetrafluoroethylene&#xD;
      (d-PTFE) and (iii) titanium-reinforced expanded polytetrafluoroethylene (Ti-e-PTFE)&#xD;
      membranes. The PTFE physico-chemical, thermal, and mechanical properties make it one of the&#xD;
      most inert materials.The microstructure of e-PTFE consists of solid nodes interconnected by&#xD;
      fine, highly oriented fibrils, providing a unique porous structure. The e-PTFE membranes,&#xD;
      first used in 1984, have different structural features at both membrane sides.Effectiveness&#xD;
      of e-PTFE membranes was investigated in numerous clinical studies, that confirmed their&#xD;
      excellent biocompatibility, leading to a significant bone regeneration after 3- and 6-month&#xD;
      healing period .However, drawbacks of e-PTFE membranes are (i) the need for a second surgical&#xD;
      procedure and (ii) membrane stiffness that may result in soft tissue dehiscence (which is the&#xD;
      cause of failure during the first 3 weeks after membrane implantation), allowing the exposure&#xD;
      of the membrane to bacterial infection.&#xD;
&#xD;
      The d-PTFE membrane, developed in 1993, is a non-resorbable membrane, consisting of a&#xD;
      high-density PTFE having submicron (0.2 μm) pores. The d-PTFE membranes do not require&#xD;
      primary closure and preserve the full width of keratinized mucosa, producing an interesting&#xD;
      advantage in respect to e-PTFE. Compared to e-PTFE membranes, the macroporosity of which&#xD;
      enhances bacterial colonization upon exposure .the density of the d-PTFE membranes (i)&#xD;
      prevents the infections as widely described by different authors .and (ii) makes membranes&#xD;
      easy to be removed.&#xD;
&#xD;
      Titanium-reinforced barrier membranes were introduced (Cytoplast® TI-250 Titanium-Reinforced)&#xD;
      by Jovanovic and Nevins . who reported the superior regenerative ability of these membranes&#xD;
      in respect to the conventional e-PTFE ones. The titanium reinforcement provides mechanical&#xD;
      support to the overlying soft tissue preventing its collapse into the defect. In addition,&#xD;
      during the surgical procedure, titanium struts permit the surgeon to easily place the&#xD;
      membrane under flaps with minimal dissection and flap reflection Native collagen membranes&#xD;
      have rapid biodegradation by the enzymatic activity of macrophages and polymorphonuclear&#xD;
      leucocytes occurs when using them. these membranes are well documented and have excellent&#xD;
      results . they have good tissue integration and vascularization from periosteal side.there is&#xD;
      a debate about what is more important biocompatibility or resorption time . The most&#xD;
      important commercial collagen membrane is Bio-Gide®, which is based on Xenogenic collagen&#xD;
      Type I form porcine skin and is characterized by a bilayered structure with a dense and a&#xD;
      porous layer. The dense layer has a smooth surface able to avoid epithelial cell infiltration&#xD;
      into bone defects, while the porous layer allows tissue integration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 26, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>each patient will be given a code by researcher and observer will be blind to which group this case belong</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>amount of bone gained</measure>
    <time_frame>6 months</time_frame>
    <description>using cbct 6 months after</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone area percentage</measure>
    <time_frame>6 months</time_frame>
    <description>Histo-morphometric analysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Missing Maxillary Anterior Teeth</condition>
  <arm_group>
    <arm_group_label>guided bone regeneration using ptfe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Augmented anterior maxillary bone ridge using ptfe with 1:1 autogenous bone and xenograft mixture&#xD;
Patients of both groups will be subjected to CBCT (diagnostic for upper arch).&#xD;
Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.&#xD;
Local anesthesia will be given to the patient.&#xD;
Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.&#xD;
intervention:&#xD;
Flap will be done.&#xD;
In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a ptfe membrane which will be stabilized by tacks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>collagen membrane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Local anesthesia will be given to the patient. intervention:&#xD;
Flap will be done.&#xD;
In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>guided bone regenerations</intervention_name>
    <description>intra oral procedures.&#xD;
Flap will be done.&#xD;
In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.&#xD;
In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks.&#xD;
The site will then be copiously irrigated with saline in preparation for closure.&#xD;
The flap will then be closed using interrupted 4/0 resorbable sutures.</description>
    <arm_group_label>collagen membrane</arm_group_label>
    <arm_group_label>guided bone regeneration using ptfe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:• Patients with atrophied anterior maxillary ridge area.&#xD;
&#xD;
          -  Age: 18 years and older.&#xD;
&#xD;
          -  Both sexes.&#xD;
&#xD;
          -  No intraoral soft and hard tissue pathology.&#xD;
&#xD;
          -  No systemic condition that contraindicate bone augmentation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Heavy smokers more than 20 cigarettes per day.(32)&#xD;
&#xD;
               -  Patients with systemic disease that may affect normal healing.&#xD;
&#xD;
               -  Psychiatric problems.&#xD;
&#xD;
               -  Disorders to bone augmentation are related to history of radiation therapy to the&#xD;
                  head and neck neoplasia.&#xD;
&#xD;
               -  Pregnant or nursing women.&#xD;
&#xD;
               -  Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or&#xD;
                  osteoporosis.&#xD;
&#xD;
               -  Patient with previous history of radiotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>• human Patients with atrophied anterior maxillary ridge area.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>bassam ahmed, priciple investigator</last_name>
    <phone>01025266868</phone>
    <email>dr.besoahmed@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mohamed atef, professor</last_name>
    <phone>01009612708</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cairo Univeristy</name>
      <address>
        <city>Giza</city>
        <state>Manial</state>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>cairo univeristy</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
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  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>bassam ahmed abd elhameed alkholi</investigator_full_name>
    <investigator_title>principle investigator (doctor)</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839615
org study id: GBR using ptfe vs collagen
nct id: NCT03839615
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe
      membrane while using a 1:1 mix of xenograft and autogenous bone
The alveolar bone is formed during tooth eruption, and consists of maxillary and mandibular
      components that shape and support the alveolar sockets. When teeth are lost, alveolar atrophy
      occurs, ultimately resulting in a short and narrow alveolar ridge . Such changes in the
      alveolar bone have a significant effect on prosthetic restoration planning, and are
      particularly important for areas with esthetic requirements, such as the maxillary incisors.
      Since preservation of the alveolar bone after extraction makes implant placement and
      prosthetic restoration easier in the edentulous jaw, alveolar ridge preservation and
      reconstruction methods using various bone graft materials together with resorbable and
      non-resorbable membranes have been introduced in order to minimize the loss of alveolar bone
      after extraction.

      Investigations of changes in the alveolar bone after extraction have frequently been
      performed through clinical measurements and radiographic analysis. In particular, after the
      extraction of a tooth with fracture or severe periodontitis, the alveolar bone shows severe
      horizontal and vertical atrophy. The reduction in the width of the alveolar ridge is more
      notable in the horizontal direction than in the vertical direction, and the buccal wall of
      the alveolar bone has been reported to undergo greater vertical atrophy than the lingual
      wall. Changes in the width of the alveolar ridge after extraction occur in a relatively short
      time, decreasing most rapidly within the first six months after extraction, followed by
      continual, slow bone resorption over the course of the rest of the patient's life .

      When a tooth has been lost, the extent of alveolar bone resorption is affected by a range of
      factors, including the number of extracted teeth and bone walls, the bone density, the extent
      of alveolar bone loss, infection, and the presence or absence of adjacent teeth.

      Dental implant has become a predictable treatment option, with excellent long-term results.
      However, the success of implant therapy depends on the amount of bone volume at the insertion
      site.Unfavorable local conditions may provide insufficient bone volume that negatively
      affects the prognosis of dental implants. Cawood and Howell in 1988 ranked the atrophy degree
      of edentulous jaws in six classes. Particularly, atrophies within class IV, also known as
      "knife-edge" ridges, present a serious horizontal defect, making challenging the placement of
      regular implants.

      Many techniques have been developed to regenerate atrophic alveolar jaws for the placement of
      dental implants, performed either in combination with graft procedures or in second stage
      surgery after a period of healing. For many years, bone blocks represented the gold standard
      to reconstruct the alveolar ridge bone defects. This technique requires to harvest a wide
      amount of bone to rebuild the atrophic crest.(20). For this reason, bone blocks were often
      harvested from extra-oral sites with an higher morbidity. Moreover some problems can occur
      when a combined defects (horizontal and vertical) need to be treated. Guided bone
      regeneration (GBR) has been proposed as a possible alternative for patients with severe
      horizontal bone atrophy, to overcome the drawback of bone blocks techniques. To protect and
      prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological
      space for the regeneration of bone tissue, the use of both non-resorbable or resorbable
      membranes, in combination with autologous or heterologous particulate bone have been
      proposed. Particulated autogenous bone can be mixed with bone substitutes to add more
      osteogenic factors.

      Guided bone regeneration or GBR, and guided tissue regeneration or GTR are dental surgical
      procedures that use barrier membranes to direct the growth of new bone and gingival tissue at
      sites with insufficient volumes or dimensions of bone or gingiva for proper function,
      esthetics or prosthetic restoration.

      GBR is similar to guided tissue regeneration (GTR) but is focused on development of hard
      tissues in addition to the soft tissues of the periodontal attachment. At present, guided
      bone regeneration is predominantly applied in the oral cavity to support new hard tissue
      growth on an alveolar ridge to allow stable placement of dental implants.

      The first application of barrier membranes in the mouth occurred in 1982. in the context of
      regeneration of periodontal tissues via GTR, as an alternative to resective surgical
      procedures to reduce pocket depths.Barrier membrane is utilized in GBR technique to cover the
      bone defect and create a secluded space, which prevents the connective tissue from growing
      into the space and facilitates the growth priority of bone tissue.

      Several surgical techniques via GBR have been proposed regarding the tri-dimensional bone
      reconstruction of the severely resorbed maxilla, using different types of bone substitutes
      that have regenerative, osseoinductive or osseoconductive properties which is then packed
      into the bony defect and covered by resorbable membranes. In cases where augmentation
      materials used are autografts or allografts the bone density is quite low and resorption of
      the grafted site in these cases can reach up to 30% of original volume. For higher
      predictability, nonresorbable titanium-reinforced d-polytetrafluoroethylene (d-PTFE)
      membranes-as a barrier against the migration of epithelial cells within the grafted site-are
      recommended.

      Non-resorbable membranes retain their shape and structure in the tissues, requiring a second
      surgical procedure for removal, with consequent additional patient discomfort, and a raise in
      the costs and duration of the therapy. Non-resorbable membranes include: (i) expanded
      polytetrafluoroethylene (e-PTFE, Gore-Tex®); (ii) high-density polytetrafluoroethylene
      (d-PTFE) and (iii) titanium-reinforced expanded polytetrafluoroethylene (Ti-e-PTFE)
      membranes. The PTFE physico-chemical, thermal, and mechanical properties make it one of the
      most inert materials.The microstructure of e-PTFE consists of solid nodes interconnected by
      fine, highly oriented fibrils, providing a unique porous structure. The e-PTFE membranes,
      first used in 1984, have different structural features at both membrane sides.Effectiveness
      of e-PTFE membranes was investigated in numerous clinical studies, that confirmed their
      excellent biocompatibility, leading to a significant bone regeneration after 3- and 6-month
      healing period .However, drawbacks of e-PTFE membranes are (i) the need for a second surgical
      procedure and (ii) membrane stiffness that may result in soft tissue dehiscence (which is the
      cause of failure during the first 3 weeks after membrane implantation), allowing the exposure
      of the membrane to bacterial infection.

      The d-PTFE membrane, developed in 1993, is a non-resorbable membrane, consisting of a
      high-density PTFE having submicron (0.2 μm) pores. The d-PTFE membranes do not require
      primary closure and preserve the full width of keratinized mucosa, producing an interesting
      advantage in respect to e-PTFE. Compared to e-PTFE membranes, the macroporosity of which
      enhances bacterial colonization upon exposure .the density of the d-PTFE membranes (i)
      prevents the infections as widely described by different authors .and (ii) makes membranes
      easy to be removed.

      Titanium-reinforced barrier membranes were introduced (Cytoplast® TI-250 Titanium-Reinforced)
      by Jovanovic and Nevins . who reported the superior regenerative ability of these membranes
      in respect to the conventional e-PTFE ones. The titanium reinforcement provides mechanical
      support to the overlying soft tissue preventing its collapse into the defect. In addition,
      during the surgical procedure, titanium struts permit the surgeon to easily place the
      membrane under flaps with minimal dissection and flap reflection Native collagen membranes
      have rapid biodegradation by the enzymatic activity of macrophages and polymorphonuclear
      leucocytes occurs when using them. these membranes are well documented and have excellent
      results . they have good tissue integration and vascularization from periosteal side.there is
      a debate about what is more important biocompatibility or resorption time . The most
      important commercial collagen membrane is Bio-Gide®, which is based on Xenogenic collagen
      Type I form porcine skin and is characterized by a bilayered structure with a dense and a
      porous layer. The dense layer has a smooth surface able to avoid epithelial cell infiltration
      into bone defects, while the porous layer allows tissue integration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: each patient will be given a code by researcher and observer will be blind to which group this case belong
measure: amount of bone gained
time frame: 6 months
description: using cbct 6 months after
measure: Bone area percentage
time frame: 6 months
description: Histo-morphometric analysis
arm group label: guided bone regeneration using ptfe
arm group type: Active Comparator
description: Augmented anterior maxillary bone ridge using ptfe with 1:1 autogenous bone and xenograft mixture
Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
Local anesthesia will be given to the patient.
Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
intervention:
Flap will be done.
In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a ptfe membrane which will be stabilized by tacks.
arm group label: collagen membrane
arm group type: Experimental
description: Local anesthesia will be given to the patient. intervention:
Flap will be done.
In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
intervention type: Procedure
intervention name: guided bone regenerations
description: intra oral procedures.
Flap will be done.
In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks.
The site will then be copiously irrigated with saline in preparation for closure.
The flap will then be closed using interrupted 4/0 resorbable sutures.
arm group label: collagen membrane
arm group label: guided bone regeneration using ptfe
criteria: 
gender: All
gender based: Yes
gender description: • human Patients with atrophied anterior maxillary ridge area.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: bassam ahmed, priciple investigator
phone: 01025266868
email: dr.besoahmed@hotmail.com
last name: mohamed atef, professor
phone: 01009612708
facility: 
contact: 
country: Egypt
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responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: bassam ahmed abd elhameed alkholi
investigator title: principle investigator (doctor)
sharing ipd: Undecided