<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/NCT03804177</url>
  </required_header>
  <id_info>
    <org_study_id>perio25111987</org_study_id>
    <nct_id>NCT03804177</nct_id>
  </id_info>
  <brief_title>The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region</brief_title>
  <official_title>The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients</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>
      The concept of immediate implant placement at the time of tooth extraction was first&#xD;
      introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining&#xD;
      different variables have supported the concept of immediate implant placement. pioneered a&#xD;
      major contribution to immediate implant placement in human studies which recommended the&#xD;
      insertion of an implant into a fresh extraction socket.&#xD;
&#xD;
      They advocated immediate implant placement primarily to reduce the number of surgical&#xD;
      interventions needed to perform an implant-supported rehabilitation and shorten the treatment&#xD;
      time.&#xD;
&#xD;
      Placement of implants immediately into extraction sites allow the surgeon to idealize the&#xD;
      position of the implant appropriately with a better rehabilitation of the normal contour to&#xD;
      the facial aspect of the final restoration.&#xD;
&#xD;
      Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone&#xD;
      resorption. Better esthetic outcomes were achieved including the prosthetic crown length in&#xD;
      harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve&#xD;
      and maximum soft tissue support.&#xD;
&#xD;
      Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of&#xD;
      biological functions including structural integrity, and the regulation of embryologic&#xD;
      development. It is described as a natural organic substance, with physiological therapy&#xD;
      activity, main component of the extracellular matrix of many tissues such as the skin,&#xD;
      synovial joints and periodontal tissues .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 10, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 10, 2022</primary_completion_date>
  <phase>Phase 4</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>it is randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>single blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>implant stability</measure>
    <time_frame>6 months</time_frame>
    <description>implant stability by ostell</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>soft tissue healing</measure>
    <time_frame>6 months</time_frame>
    <description>soft tissue healing by likert scale (0 indicate complete soft tissue Closure (no line of fibrin) , 1 indicate complete closure (thin line of fibrin) , 2 indcate complete closure (fibrin) , 3 indicate in complete closure (dehiscence ) , 4 indicate incomplete closure (necrosis)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Immediate Dental Implant</condition>
  <arm_group>
    <arm_group_label>implant with hyaluronic melatonin vit c</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>immediate implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>immediate implant placement alone without melatonin or hyauronic acid nor vitamin c</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>immediate implant placement with melatonin hyaluronic acid vit C</intervention_name>
    <description>immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C</description>
    <arm_group_label>implant with hyaluronic melatonin vit c</arm_group_label>
    <other_name>early implant placement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>immediate implant placement without melatonin hyaluronic acid vit C</intervention_name>
    <description>immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C</description>
    <arm_group_label>immediate implant</arm_group_label>
    <other_name>early implant placement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18-60.&#xD;
&#xD;
          2. Systemically healthy patients indicated for single or multiple immediate implants in&#xD;
             anterior and premolar region.&#xD;
&#xD;
          3. Absence of any peri-apical pathosis.&#xD;
&#xD;
          4. Patients with intact buccal plate of bone.&#xD;
&#xD;
          5. Patients with adequate bone volume for the dental implant procedure.&#xD;
&#xD;
          6. Patient consent approval and signing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Smokers. 2. Systemic disease that may affect the final outcome of the surgical&#xD;
             procedure.&#xD;
&#xD;
             3. No or poor patient's compliance. 4. Patients with psychological problems. 5.&#xD;
             Pathology at the site of intervention. 6. Pregnant patients. 7. Patients refuse to&#xD;
             sign an informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona darhous, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mona shoieb, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ahmed Nasser, Msc</last_name>
    <phone>00201094959526</phone>
    <email>ahmedelsawi8787@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Lee JH, Kim J, Baek HR, Lee KM, Seo JH, Lee HK, Lee AY, Zheng GB, Chang BS, Lee CK. Fabrication of an rhBMP-2 loaded porous beta-TCP microsphere-hyaluronic acid-based powder gel composite and evaluation of implant osseointegration. J Mater Sci Mater Med. 2014 Sep;25(9):2141-51. doi: 10.1007/s10856-014-5250-0. Epub 2014 Jun 14.</citation>
    <PMID>24928668</PMID>
  </reference>
  <reference>
    <citation>El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.</citation>
    <PMID>26103559</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Nabil Abdelfatiah</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>immediate implant</keyword>
  <keyword>hyaluronic acid</keyword>
  <keyword>melatonin</keyword>
  <keyword>vitamin C</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
    <mesh_term>Melatonin</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>i will check with my study chair</ipd_description>
  </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/NCT03804177
org study id: perio25111987
nct id: NCT03804177
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The concept of immediate implant placement at the time of tooth extraction was first
      introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining
      different variables have supported the concept of immediate implant placement. pioneered a
      major contribution to immediate implant placement in human studies which recommended the
      insertion of an implant into a fresh extraction socket.

      They advocated immediate implant placement primarily to reduce the number of surgical
      interventions needed to perform an implant-supported rehabilitation and shorten the treatment
      time.

      Placement of implants immediately into extraction sites allow the surgeon to idealize the
      position of the implant appropriately with a better rehabilitation of the normal contour to
      the facial aspect of the final restoration.

      Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone
      resorption. Better esthetic outcomes were achieved including the prosthetic crown length in
      harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve
      and maximum soft tissue support.

      Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of
      biological functions including structural integrity, and the regulation of embryologic
      development. It is described as a natural organic substance, with physiological therapy
      activity, main component of the extracellular matrix of many tissues such as the skin,
      synovial joints and periodontal tissues .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: it is randomized clinical trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: single blinded
measure: implant stability
time frame: 6 months
description: implant stability by ostell
measure: soft tissue healing
time frame: 6 months
description: soft tissue healing by likert scale (0 indicate complete soft tissue Closure (no line of fibrin) , 1 indicate complete closure (thin line of fibrin) , 2 indcate complete closure (fibrin) , 3 indicate in complete closure (dehiscence ) , 4 indicate incomplete closure (necrosis)
arm group label: implant with hyaluronic melatonin vit c
arm group type: Experimental
description: implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C
arm group label: immediate implant
arm group type: Active Comparator
description: immediate implant placement alone without melatonin or hyauronic acid nor vitamin c
intervention type: Procedure
intervention name: immediate implant placement with melatonin hyaluronic acid vit C
description: immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C
arm group label: implant with hyaluronic melatonin vit c
other name: early implant placement
intervention type: Procedure
intervention name: immediate implant placement without melatonin hyaluronic acid vit C
description: immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C
arm group label: immediate implant
other name: early implant placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mona darhous, PHD
role: Study Chair
affiliation: Cairo University
last name: Mona shoieb, PHD
role: Study Chair
affiliation: Cairo University
last name: ahmed Nasser, Msc
phone: 00201094959526
email: ahmedelsawi8787@gmail.com
citation: Lee JH, Kim J, Baek HR, Lee KM, Seo JH, Lee HK, Lee AY, Zheng GB, Chang BS, Lee CK. Fabrication of an rhBMP-2 loaded porous beta-TCP microsphere-hyaluronic acid-based powder gel composite and evaluation of implant osseointegration. J Mater Sci Mater Med. 2014 Sep;25(9):2141-51. doi: 10.1007/s10856-014-5250-0. Epub 2014 Jun 14.
PMID: 24928668
citation: El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.
PMID: 26103559
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Nabil Abdelfatiah
investigator title: assistant lecturer
mesh term: Ascorbic Acid
mesh term: Melatonin
mesh term: Hyaluronic Acid
sharing ipd: Undecided
ipd description: i will check with my study chair