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/NCT06033989</url>
    </required_header>
    <id_info>
      <org_study_id>Shihanah1993</org_study_id>
      <nct_id>NCT06033989</nct_id>
    </id_info>
    <brief_title>Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.</brief_title>
    <official_title>Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched Surface Treatment on Stability of Delayed Dental Implant in Posterior Maxilla. Comparative Randomized Clinical Trial (RCT).</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>No</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>
        Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment&#xD;
        Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A dental implant is one of the procedures to restore missing teeth , to achieved the&#xD;
        stability for implant success is the direct growth of bone to the implant surface, known as&#xD;
        Osseointegration.As a result, bone stability around dental implants is determined by factors&#xD;
        that the implantologist may or may not directly influence, such as local bone quality and&#xD;
        bone metabolism, as well as systemic factors such as age, systematic chronic diseases and&#xD;
        lifestyle (e.g., smoking habits).Treatment-related factors include augmentation material,&#xD;
        implant design (macro and micro), surgical procedures, and loading protocols. Therefore , it&#xD;
        may be needed for a surface treatment could alter the topography, chemical content, and&#xD;
        roughness of the surface and result in various biological reactions. The surface treatment&#xD;
        can also increase the area of contact between the implant and the supporting bone . The&#xD;
        rationale is evaluate Increasing the implant stability around implants placed by using&#xD;
        hyaluronic acid that act to improving the connection between implant and bone .Sandblasting&#xD;
        and acid etching is the most commonly used basic method for modifying the surface of dental&#xD;
        implants . the sandblasting procedure &quot;roughs up&quot; the outer layer of the implant,creating a&#xD;
        surface that is easier for the bone to grip as the implant heals.While hyaluronic acid and&#xD;
        its derivatives have a strong chance of osseointegration and mineralization and have been&#xD;
        utilized extensively for bone repair.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Implant stability</measure>
      <time_frame>0-3 months</time_frame>
      <description>It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>soft tissue healing</measure>
      <time_frame>10 days</time_frame>
      <description>It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bone density</measure>
      <time_frame>3 months</time_frame>
      <description>It is assessed by using CBCT To determine the density of bone after intervention</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Missing Teeth</condition>
    <condition>Bone Loss</condition>
    <arm_group>
      <arm_group_label>Hyaluronic acids</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hyaluronic acid has a huge potential to speed up the healing process and increase implant stability by enhancing bone/implant interaction and new bone formation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sandblasting acid etched</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure &quot;roughs up&quot; the outer layer of the implant , creating a surface that is easier for the bone to grip as the implant heals.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hyaluronic acid</intervention_name>
      <description>Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .</description>
      <arm_group_label>Hyaluronic acids</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>sandblasted, and acid-etched</intervention_name>
      <description>Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .</description>
      <arm_group_label>Sandblasting acid etched</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Delayed dental implant</intervention_name>
      <description>Surgical procedure of delayed dental implant in posterior maxilla after application of surface treatment to enhance Osseointegration and healing .</description>
      <arm_group_label>Hyaluronic acids</arm_group_label>
      <arm_group_label>Sandblasting acid etched</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with missing teeth in posterior maxilla.&#xD;
  &#xD;
            -  Both genders males and females will be included.&#xD;
  &#xD;
            -  Age from 18-60 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  General contraindications to implant surgery.&#xD;
  &#xD;
            -  Subjected to irradiation in the head and neck area less than 1 year before&#xD;
               implantation.&#xD;
  &#xD;
            -  Untreated periodontitis.&#xD;
  &#xD;
            -  Poor oral hygiene and motivation.&#xD;
  &#xD;
            -  Uncontrolled diabetes.&#xD;
  &#xD;
            -  Pregnant or nursing.&#xD;
  &#xD;
            -  Substance abuse.&#xD;
  &#xD;
            -  Psychiatric problems or unrealistic expectations.&#xD;
  &#xD;
            -  Severe bruxism or clenching.&#xD;
  &#xD;
            -  Immunosuppressed or immunocompromised.&#xD;
  &#xD;
            -  Treated or under treatment with intravenous amino-bisphosphonates.&#xD;
  &#xD;
            -  Active infection or severe inflammation in the area intended for implant placement.&#xD;
  &#xD;
            -  Unable to open mouth sufficiently to accommodate the surgical tooling.&#xD;
  &#xD;
            -  Patients participating in other studies, if the present protocol could not be properly&#xD;
               followed.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shihanah Alkashi, BSc</last_name>
      <phone>00966542044424</phone>
      <email>Shihanah.yousef@dentistry.cu.edu.eg</email>
    </overall_contact>
    <reference>
      <citation>Peck MT, Marnewick J, Stephen L. Alveolar ridge preservation using leukocyte and platelet-rich fibrin: a report of a case. Case Rep Dent. 2011;2011:345048. doi: 10.1155/2011/345048. Epub 2011 Jul 3.</citation>
      <PMID>22567435</PMID>
    </reference>
    <reference>
      <citation>Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.</citation>
      <PMID>9922740</PMID>
    </reference>
    <reference>
      <citation>Velasco-Ortega E, Jimenez-Guerra A, Monsalve-Guil L, Ortiz-Garcia I, Nicolas-Silvente AI, Segura-Egea JJ, Lopez-Lopez J. Long-Term Clinical Outcomes of Treatment with Dental Implants with Acid Etched Surface. Materials (Basel). 2020 Mar 27;13(7):1553. doi: 10.3390/ma13071553.</citation>
      <PMID>32230917</PMID>
    </reference>
    <reference>
      <citation>Massaro C, Rotolo P, De Riccardis F, Milella E, Napoli A, Wieland M, Textor M, Spencer ND, Brunette DM. Comparative investigation of the surface properties of commercial titanium dental implants. Part I: chemical composition. J Mater Sci Mater Med. 2002 Jun;13(6):535-48. doi: 10.1023/a:1015170625506.</citation>
      <PMID>15348583</PMID>
    </reference>
    <reference>
      <citation>Cervino G, Meto A, Fiorillo L, Odorici A, Meto A, D'Amico C, Oteri G, Cicciu M. Surface Treatment of the Dental Implant with Hyaluronic Acid: An Overview of Recent Data. Int J Environ Res Public Health. 2021 Apr 27;18(9):4670. doi: 10.3390/ijerph18094670.</citation>
      <PMID>33925742</PMID>
    </reference>
    <results_reference>
      <citation>Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/</citation>
      <PMID>29262027</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Shihanah Yousef Ahmed Alkashi</investigator_full_name>
      <investigator_title>Master's degree candidate</investigator_title>
    </responsible_party>
    <keyword>Dental implant</keyword>
    <keyword>Stability</keyword>
    <keyword>Osseointegration</keyword>
    <keyword>Hyaluronic acid</keyword>
    <keyword>Sandblasted acid etched</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tooth Loss</mesh_term>
      <mesh_term>Anodontia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyaluronic Acid</mesh_term>
    </intervention_browse>
    <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/NCT06033989
  org study id: Shihanah1993
  nct id: NCT06033989
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment
        Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.
  A dental implant is one of the procedures to restore missing teeth , to achieved the
        stability for implant success is the direct growth of bone to the implant surface, known as
        Osseointegration.As a result, bone stability around dental implants is determined by factors
        that the implantologist may or may not directly influence, such as local bone quality and
        bone metabolism, as well as systemic factors such as age, systematic chronic diseases and
        lifestyle (e.g., smoking habits).Treatment-related factors include augmentation material,
        implant design (macro and micro), surgical procedures, and loading protocols. Therefore , it
        may be needed for a surface treatment could alter the topography, chemical content, and
        roughness of the surface and result in various biological reactions. The surface treatment
        can also increase the area of contact between the implant and the supporting bone . The
        rationale is evaluate Increasing the implant stability around implants placed by using
        hyaluronic acid that act to improving the connection between implant and bone .Sandblasting
        and acid etching is the most commonly used basic method for modifying the surface of dental
        implants . the sandblasting procedure "roughs up" the outer layer of the implant,creating a
        surface that is easier for the bone to grip as the implant heals.While hyaluronic acid and
        its derivatives have a strong chance of osseointegration and mineralization and have been
        utilized extensively for bone repair.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Implant stability
  time frame: 0-3 months
  description: It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .
  measure: soft tissue healing
  time frame: 10 days
  description: It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .
  measure: bone density
  time frame: 3 months
  description: It is assessed by using CBCT To determine the density of bone after intervention
  arm group label: Hyaluronic acids
  arm group type: Experimental
  description: Hyaluronic acid has a huge potential to speed up the healing process and increase implant stability by enhancing bone/implant interaction and new bone formation.
  arm group label: Sandblasting acid etched
  arm group type: Active Comparator
  description: Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant , creating a surface that is easier for the bone to grip as the implant heals.
  intervention type: Drug
  intervention name: Hyaluronic acid
  description: Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .
  arm group label: Hyaluronic acids
  intervention type: Drug
  intervention name: sandblasted, and acid-etched
  description: Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .
  arm group label: Sandblasting acid etched
  intervention type: Procedure
  intervention name: Delayed dental implant
  description: Surgical procedure of delayed dental implant in posterior maxilla after application of surface treatment to enhance Osseointegration and healing .
  arm group label: Hyaluronic acids
  arm group label: Sandblasting acid etched
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shihanah Alkashi, BSc
  phone: 00966542044424
  email: Shihanah.yousef@dentistry.cu.edu.eg
  citation: Peck MT, Marnewick J, Stephen L. Alveolar ridge preservation using leukocyte and platelet-rich fibrin: a report of a case. Case Rep Dent. 2011;2011:345048. doi: 10.1155/2011/345048. Epub 2011 Jul 3.
  PMID: 22567435
  citation: Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.
  PMID: 9922740
  citation: Velasco-Ortega E, Jimenez-Guerra A, Monsalve-Guil L, Ortiz-Garcia I, Nicolas-Silvente AI, Segura-Egea JJ, Lopez-Lopez J. Long-Term Clinical Outcomes of Treatment with Dental Implants with Acid Etched Surface. Materials (Basel). 2020 Mar 27;13(7):1553. doi: 10.3390/ma13071553.
  PMID: 32230917
  citation: Massaro C, Rotolo P, De Riccardis F, Milella E, Napoli A, Wieland M, Textor M, Spencer ND, Brunette DM. Comparative investigation of the surface properties of commercial titanium dental implants. Part I: chemical composition. J Mater Sci Mater Med. 2002 Jun;13(6):535-48. doi: 10.1023/a:1015170625506.
  PMID: 15348583
  citation: Cervino G, Meto A, Fiorillo L, Odorici A, Meto A, D'Amico C, Oteri G, Cicciu M. Surface Treatment of the Dental Implant with Hyaluronic Acid: An Overview of Recent Data. Int J Environ Res Public Health. 2021 Apr 27;18(9):4670. doi: 10.3390/ijerph18094670.
  PMID: 33925742
  citation: Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/
  PMID: 29262027
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Shihanah Yousef Ahmed Alkashi
  investigator title: Master's degree candidate
  mesh term: Tooth Loss
  mesh term: Anodontia
  mesh term: Hyaluronic Acid
  sharing ipd: No