xml: <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/NCT05982353</url>
    </required_header>
    <id_info>
      <org_study_id>PTFEvsGelatin</org_study_id>
      <nct_id>NCT05982353</nct_id>
    </id_info>
    <brief_title>Gelatin Sponge VS PTFE Membrane for Socket Sealing After Immediate Implant Placement</brief_title>
    <official_title>Effect of Using a Hemostatic Gelatin Sponge Versus a Dense Polytetrafluorethylene Membrane for Socket Sealing Following Immediate Implant Placement. A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Research Centre, Egypt</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Digital panoramas will be made to assess the implant sites. The included patients are&#xD;
        assigned to their respective groups randomly. After implant submerging in the study group 2&#xD;
        layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the&#xD;
        control group PTFE is fixed. After 3 weeks the PTFE was removed while the gelatin sponge&#xD;
        should be resorbed. 3 months later the implants are to be assessed for stability and a&#xD;
        reverse torque test was used to confirm osseointegration during uncovering.&#xD;
  &#xD;
        Follow-up appointments at 1,3 weeks and 1,2 &amp; 3 months were planned.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dental implants are considered the gold standard for treatment of edentulous spaces.&#xD;
        Immediate implant placement has multiple advantages including the shorter treatment span,&#xD;
        less surgical procedures and faster loading possibility [1]. One of the drawbacks of&#xD;
        immediate implant placement is proper soft tissue coverage of the submerged implant to&#xD;
        prevent socket infection and allow implant stability and osseointegration [2]. To overcome&#xD;
        these issues the use of membranes has been the standard procedure [3].&#xD;
  &#xD;
        Polytetrafluoroethylene membranes (PTFE) have been reported vastly in literature and their&#xD;
        results and clinical effect on soft tissue healing and guided tissue regeneration (GTR)&#xD;
        around implants and in surgical sites. Dense PTFE allows for GTR by only promoting&#xD;
        non-bacterial migration and improving cellular adhesion which promotes tissue regeneration&#xD;
        underneath it [4]. On the other hand, PTFE membranes are quite expensive and with the&#xD;
        economic crisis the world is facing the use of other less expensive options is crucial.&#xD;
        Gelatin sponges are vastly used as hemostatic agents in minor surgical procedures and have&#xD;
        shown excellent results in terms of hemostasis and rapid resorption [5]. The application of&#xD;
        such material are multiple; such as with sinus lift procedures [6], microvascular&#xD;
        decompression[7] and as a wound dressing [8].&#xD;
  &#xD;
        The investigators hereby propose the use of hemostatic gelatin sponges as membranes for&#xD;
        submerged immediate implants as a simpler and cheaper alternative to PTFE.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
    <phase>Early Phase 1</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>
      <intervention_model_description>patients with dental sockets requiring immediate implantation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>blinded envelopes selected by operator</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>reverse torque test</measure>
      <time_frame>3 months after implant placement</time_frame>
      <description>the implants will be subjected to a reverse torque test of 30 N/cm using a calibrated torque wrench. this should identify proper osseointegration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical soft tissue healing</measure>
      <time_frame>2,3 weeks and 3 months</time_frame>
      <description>incidence of infection/ improper tissue closure/dehiscence. will be assessed by to different blinded investigators using the IPR scoring scale</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Immediate Implantation</condition>
    <condition>Badly Broken Down Tooth</condition>
    <condition>Gelatin Sponge for Socket Healing</condition>
    <arm_group>
      <arm_group_label>PTFE application with immediate implantation</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>this group received PTFE membranes during immediate implantation as the gold standard</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gelatin Sponge application with immediate implantation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>this group received gelatin sponges during immediate implant placement</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PTFE application</intervention_name>
      <description>Polytetrafluoroethylene membrane vs gelatin sponge used over immediate implants</description>
      <arm_group_label>Gelatin Sponge application with immediate implantation</arm_group_label>
      <arm_group_label>PTFE application with immediate implantation</arm_group_label>
      <other_name>Gelatin sponge application</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with badly broken down tooth indicated for immediate implantation&#xD;
  &#xD;
            -  generally healthy patients 22-50 years of age&#xD;
  &#xD;
            -  non smokers&#xD;
  &#xD;
            -  good oral hygiene&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  poor bone quality&#xD;
  &#xD;
            -  poor oral hygiene&#xD;
  &#xD;
            -  non compliant patient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Noha ElAdl, PhD</last_name>
      <role>Study Director</role>
      <affiliation>National Research Centre, Egypt</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Research centre</name>
        <address>
          <city>Cairo</city>
          <zip>11234</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.</citation>
      <PMID>28000278</PMID>
    </reference>
    <reference>
      <citation>Araujo MG, Silva CO, Souza AB, Sukekava F. Socket healing with and without immediate implant placement. Periodontol 2000. 2019 Feb;79(1):168-177. doi: 10.1111/prd.12252.</citation>
      <PMID>30892762</PMID>
    </reference>
    <reference>
      <citation>El Helow K, El Askary Ael S. Regenerative barriers in immediate implant placement: a literature review. Implant Dent. 2008 Sep;17(3):360-71. doi: 10.1097/ID.0b013e3181813406.</citation>
      <PMID>18784536</PMID>
    </reference>
    <reference>
      <citation>Carbonell JM, Martin IS, Santos A, Pujol A, Sanz-Moliner JD, Nart J. High-density polytetrafluoroethylene membranes in guided bone and tissue regeneration procedures: a literature review. Int J Oral Maxillofac Surg. 2014 Jan;43(1):75-84. doi: 10.1016/j.ijom.2013.05.017. Epub 2013 Jun 28.</citation>
      <PMID>23810680</PMID>
    </reference>
    <reference>
      <citation>Sharifi S, Maleki Dizaj S, Ahmadian E, Karimpour A, Maleki A, Memar MY, Ghavimi MA, Dalir Abdolahinia E, Goh KW. A Biodegradable Flexible Micro/Nano-Structured Porous Hemostatic Dental Sponge. Nanomaterials (Basel). 2022 Sep 30;12(19):3436. doi: 10.3390/nano12193436.</citation>
      <PMID>36234564</PMID>
    </reference>
    <reference>
      <citation>Sohn DS, Moon JW, Moon KN, Cho SC, Kang PS. New bone formation in the maxillary sinus using only absorbable gelatin sponge. J Oral Maxillofac Surg. 2010 Jun;68(6):1327-33. doi: 10.1016/j.joms.2010.02.014.</citation>
      <PMID>20493382</PMID>
    </reference>
    <reference>
      <citation>Chang B, Tang Y, Wei X, Li S. A New Application of Gelatin Sponge in the Treatment of Hemifacial Spasm by Microvascular Decompression: A Technical Note. J Neurol Surg A Cent Eur Neurosurg. 2022 Mar;83(2):183-186. doi: 10.1055/s-0040-1720994. Epub 2021 May 19.</citation>
      <PMID>34010981</PMID>
    </reference>
    <reference>
      <citation>Chanu NR, Bhattacharya K, Marbaniang D, Pal P, Ray S, Mazumder B. Evaluation of a novel melatonin-loaded gelatin sponge as a wound dressing. J Vasc Nurs. 2022 Mar;40(1):2-10. doi: 10.1016/j.jvn.2021.09.004. Epub 2021 Oct 20.</citation>
      <PMID>35287830</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Alaa Emara</investigator_full_name>
      <investigator_title>A.Professor OMFS</investigator_title>
    </responsible_party>
    <keyword>PTFE</keyword>
    <keyword>immediate Implantation</keyword>
    <keyword>Gelatin sponge</keyword>
    <keyword>Dental socket</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982353
  org study id: PTFEvsGelatin
  nct id: NCT05982353
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Digital panoramas will be made to assess the implant sites. The included patients are
        assigned to their respective groups randomly. After implant submerging in the study group 2
        layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the
        control group PTFE is fixed. After 3 weeks the PTFE was removed while the gelatin sponge
        should be resorbed. 3 months later the implants are to be assessed for stability and a
        reverse torque test was used to confirm osseointegration during uncovering.
  
        Follow-up appointments at 1,3 weeks and 1,2 & 3 months were planned.
  Dental implants are considered the gold standard for treatment of edentulous spaces.
        Immediate implant placement has multiple advantages including the shorter treatment span,
        less surgical procedures and faster loading possibility [1]. One of the drawbacks of
        immediate implant placement is proper soft tissue coverage of the submerged implant to
        prevent socket infection and allow implant stability and osseointegration [2]. To overcome
        these issues the use of membranes has been the standard procedure [3].
  
        Polytetrafluoroethylene membranes (PTFE) have been reported vastly in literature and their
        results and clinical effect on soft tissue healing and guided tissue regeneration (GTR)
        around implants and in surgical sites. Dense PTFE allows for GTR by only promoting
        non-bacterial migration and improving cellular adhesion which promotes tissue regeneration
        underneath it [4]. On the other hand, PTFE membranes are quite expensive and with the
        economic crisis the world is facing the use of other less expensive options is crucial.
        Gelatin sponges are vastly used as hemostatic agents in minor surgical procedures and have
        shown excellent results in terms of hemostasis and rapid resorption [5]. The application of
        such material are multiple; such as with sinus lift procedures [6], microvascular
        decompression[7] and as a wound dressing [8].
  
        The investigators hereby propose the use of hemostatic gelatin sponges as membranes for
        submerged immediate implants as a simpler and cheaper alternative to PTFE.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: patients with dental sockets requiring immediate implantation
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: blinded envelopes selected by operator
  measure: reverse torque test
  time frame: 3 months after implant placement
  description: the implants will be subjected to a reverse torque test of 30 N/cm using a calibrated torque wrench. this should identify proper osseointegration.
  measure: Clinical soft tissue healing
  time frame: 2,3 weeks and 3 months
  description: incidence of infection/ improper tissue closure/dehiscence. will be assessed by to different blinded investigators using the IPR scoring scale
  arm group label: PTFE application with immediate implantation
  arm group type: Sham Comparator
  description: this group received PTFE membranes during immediate implantation as the gold standard
  arm group label: Gelatin Sponge application with immediate implantation
  arm group type: Experimental
  description: this group received gelatin sponges during immediate implant placement
  intervention type: Other
  intervention name: PTFE application
  description: Polytetrafluoroethylene membrane vs gelatin sponge used over immediate implants
  arm group label: Gelatin Sponge application with immediate implantation
  arm group label: PTFE application with immediate implantation
  other name: Gelatin sponge application
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Noha ElAdl, PhD
  role: Study Director
  affiliation: National Research Centre, Egypt
  facility: 
  country: Egypt
  citation: Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.
  PMID: 28000278
  citation: Araujo MG, Silva CO, Souza AB, Sukekava F. Socket healing with and without immediate implant placement. Periodontol 2000. 2019 Feb;79(1):168-177. doi: 10.1111/prd.12252.
  PMID: 30892762
  citation: El Helow K, El Askary Ael S. Regenerative barriers in immediate implant placement: a literature review. Implant Dent. 2008 Sep;17(3):360-71. doi: 10.1097/ID.0b013e3181813406.
  PMID: 18784536
  citation: Carbonell JM, Martin IS, Santos A, Pujol A, Sanz-Moliner JD, Nart J. High-density polytetrafluoroethylene membranes in guided bone and tissue regeneration procedures: a literature review. Int J Oral Maxillofac Surg. 2014 Jan;43(1):75-84. doi: 10.1016/j.ijom.2013.05.017. Epub 2013 Jun 28.
  PMID: 23810680
  citation: Sharifi S, Maleki Dizaj S, Ahmadian E, Karimpour A, Maleki A, Memar MY, Ghavimi MA, Dalir Abdolahinia E, Goh KW. A Biodegradable Flexible Micro/Nano-Structured Porous Hemostatic Dental Sponge. Nanomaterials (Basel). 2022 Sep 30;12(19):3436. doi: 10.3390/nano12193436.
  PMID: 36234564
  citation: Sohn DS, Moon JW, Moon KN, Cho SC, Kang PS. New bone formation in the maxillary sinus using only absorbable gelatin sponge. J Oral Maxillofac Surg. 2010 Jun;68(6):1327-33. doi: 10.1016/j.joms.2010.02.014.
  PMID: 20493382
  citation: Chang B, Tang Y, Wei X, Li S. A New Application of Gelatin Sponge in the Treatment of Hemifacial Spasm by Microvascular Decompression: A Technical Note. J Neurol Surg A Cent Eur Neurosurg. 2022 Mar;83(2):183-186. doi: 10.1055/s-0040-1720994. Epub 2021 May 19.
  PMID: 34010981
  citation: Chanu NR, Bhattacharya K, Marbaniang D, Pal P, Ray S, Mazumder B. Evaluation of a novel melatonin-loaded gelatin sponge as a wound dressing. J Vasc Nurs. 2022 Mar;40(1):2-10. doi: 10.1016/j.jvn.2021.09.004. Epub 2021 Oct 20.
  PMID: 35287830
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Alaa Emara
  investigator title: A.Professor OMFS
  sharing ipd: No