<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/NCT03252366</url>
  </required_header>
  <id_info>
    <org_study_id>MI.cairouniversity</org_study_id>
    <nct_id>NCT03252366</nct_id>
  </id_info>
  <brief_title>Maxillary Sinus Elevation and Simultaneous Implant Placement</brief_title>
  <official_title>MAXILLARY SINUS ELEVATION USING GELFOAM (ABSORBABLE GELATIN) VERSUS XENOGRAFT (TUTOGEN) and SIMULTANEOUS IMPLANT PLACEMENT: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>
      using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space&#xD;
      maintainer and alternative to bone filler for new bone formation in the maxillary sinus and&#xD;
      its advantages for patients undergoing maxillary sinus elevation with simultaneous implant&#xD;
      placement as regards the implant stability and amount of bone height gain compared to&#xD;
      conventional maxillary sinus elevation by xenograft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the main problem for posterior maxilla it becomes atrophic after extraction of the&#xD;
      teeth and this followed by Pneumatization of the maxillary sinus, the atrophy of the alveolar&#xD;
      process is a common reason for the limited availability of alveolar bone for implant&#xD;
      placement in the posterior maxilla.&#xD;
&#xD;
      Numerous techniques designed to increase bone volume in the maxillary sinus region have been&#xD;
      proposed. They were mostly based on the insertion of various materials into a void created&#xD;
      between the sinus (Schneiderian) membrane and the bony walls of the maxillary sinus. (Sohn et&#xD;
      al 2008) reported simultaneous placement of implants, and insertion of gelatin sponges&#xD;
      demonstrate new bone formation through clinical and radiographic evaluations. New bone&#xD;
      formation was verified by stabilization of the elevated sinus membrane from the tenting&#xD;
      effect of placement of dental implants and absorbable gelatin sponge without any bone graft&#xD;
      material. This study shows that there is great potential for new bone formation in the&#xD;
      maxillary sinus without the use of additional bone grafts. Systemic review showed that the&#xD;
      survival rate for implants utilizing xenografts was statistically the same as for implants&#xD;
      placed in particulate autogenous bone grafts .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of bone gained:</measure>
    <time_frame>6 month</time_frame>
    <description>using linear measurements from Cone beam computed tomography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Maxillary Sinus</condition>
  <arm_group>
    <arm_group_label>GELFOAM (ABSORBABLE GELATIN)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sterile Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic.&#xD;
it act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids its effect appears to be more physical than the result of altering the blood clotting mechanism. When placed in soft tissues, GELFOAM is usually absorbed completely within four to six weeks, without inducing excessive scar tissue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XENOGRAFT (TUTOGEN)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>xenografts as a sinus bone replacement graft ,The osteoconductive properties of xenografts in human sinus grafting have been well documented. They are due to both their chemical composition and their macro and micro morphology.The efficacy of xenografts as a sinus bone replacement graft may be due to combination of factors. Foremost would be the osteoconductive capacity of xenografts. In addition, they supply minerals that are necessary for bone formation, their density provides stability to the graft and the implants placed in them, and this density persists long term due to the fact that these grafts do not completely resorb.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GELFOAM</intervention_name>
    <description>Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.&#xD;
A diamond bur will be used to make a rectangular osteotomy.&#xD;
The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.&#xD;
Implant stability will be measured by osteal device&#xD;
implant will be inserted with gelfoam (absorbable gelatin) for augmentation• The flap 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>GELFOAM (ABSORBABLE GELATIN)</arm_group_label>
    <other_name>(ABSORBABLE GELATIN)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>xenograft</intervention_name>
    <description>Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.&#xD;
A diamond bur will be used to make a rectangular osteotomy.&#xD;
The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.&#xD;
Implant stability will be measured by osteal device&#xD;
implants will be inserted with xenograft for augmentation.• The flap 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>XENOGRAFT (TUTOGEN)</arm_group_label>
    <other_name>TUTOGEN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:• Patients with atrophic maxilla and pneumatization of the maxillary&#xD;
        sinus with residual bone height from 3 to 5mm .&#xD;
&#xD;
          -  Both sexes.&#xD;
&#xD;
          -  No intraoral soft and hard tissue pathology.&#xD;
&#xD;
          -  No systemic condition that contraindicate implant placement.&#xD;
&#xD;
        Exclusion Criteria:• Sinus pathology.&#xD;
&#xD;
          -  Heavy smokers more than 20 cigarettes per day .&#xD;
&#xD;
          -  Patients with systemic disease that may affect normal healing.&#xD;
&#xD;
          -  Psychiatric problems.&#xD;
&#xD;
          -  Disorders to implant are related to history of radiation therapy to the head and neck&#xD;
             neoplasia, or bone augmentation to implant site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>fatma fawzy kandel</investigator_full_name>
    <investigator_title>Master degree student</investigator_title>
  </responsible_party>
  <keyword>MAXILLARY SINUS ELEVATION ,Simultaneous implant placement</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gelatin Sponge, Absorbable</mesh_term>
  </intervention_browse>
  <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/NCT03252366
org study id: MI.cairouniversity
nct id: NCT03252366
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space
      maintainer and alternative to bone filler for new bone formation in the maxillary sinus and
      its advantages for patients undergoing maxillary sinus elevation with simultaneous implant
      placement as regards the implant stability and amount of bone height gain compared to
      conventional maxillary sinus elevation by xenograft.
One of the main problem for posterior maxilla it becomes atrophic after extraction of the
      teeth and this followed by Pneumatization of the maxillary sinus, the atrophy of the alveolar
      process is a common reason for the limited availability of alveolar bone for implant
      placement in the posterior maxilla.

      Numerous techniques designed to increase bone volume in the maxillary sinus region have been
      proposed. They were mostly based on the insertion of various materials into a void created
      between the sinus (Schneiderian) membrane and the bony walls of the maxillary sinus. (Sohn et
      al 2008) reported simultaneous placement of implants, and insertion of gelatin sponges
      demonstrate new bone formation through clinical and radiographic evaluations. New bone
      formation was verified by stabilization of the elevated sinus membrane from the tenting
      effect of placement of dental implants and absorbable gelatin sponge without any bone graft
      material. This study shows that there is great potential for new bone formation in the
      maxillary sinus without the use of additional bone grafts. Systemic review showed that the
      survival rate for implants utilizing xenografts was statistically the same as for implants
      placed in particulate autogenous bone grafts .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Amount of bone gained:
time frame: 6 month
description: using linear measurements from Cone beam computed tomography
arm group label: GELFOAM (ABSORBABLE GELATIN)
arm group type: Active Comparator
description: Sterile Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic.
it act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids its effect appears to be more physical than the result of altering the blood clotting mechanism. When placed in soft tissues, GELFOAM is usually absorbed completely within four to six weeks, without inducing excessive scar tissue
arm group label: XENOGRAFT (TUTOGEN)
arm group type: Active Comparator
description: xenografts as a sinus bone replacement graft ,The osteoconductive properties of xenografts in human sinus grafting have been well documented. They are due to both their chemical composition and their macro and micro morphology.The efficacy of xenografts as a sinus bone replacement graft may be due to combination of factors. Foremost would be the osteoconductive capacity of xenografts. In addition, they supply minerals that are necessary for bone formation, their density provides stability to the graft and the implants placed in them, and this density persists long term due to the fact that these grafts do not completely resorb.
intervention type: Device
intervention name: GELFOAM
description: Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.
A diamond bur will be used to make a rectangular osteotomy.
The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.
Implant stability will be measured by osteal device
implant will be inserted with gelfoam (absorbable gelatin) for augmentation• The flap 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: GELFOAM (ABSORBABLE GELATIN)
other name: (ABSORBABLE GELATIN)
intervention type: Device
intervention name: xenograft
description: Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.
A diamond bur will be used to make a rectangular osteotomy.
The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.
Implant stability will be measured by osteal device
implants will be inserted with xenograft for augmentation.• The flap 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: XENOGRAFT (TUTOGEN)
other name: TUTOGEN
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: fatma fawzy kandel
investigator title: Master degree student
mesh term: Gelatin Sponge, Absorbable
sharing ipd: Undecided