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/NCT06034171</url>
    </required_header>
    <id_info>
      <org_study_id>SM-SGS_001</org_study_id>
      <nct_id>NCT06034171</nct_id>
    </id_info>
    <brief_title>Clinical Study of Implants With Modified Surface Treatment</brief_title>
    <official_title>Clinical Study of Implants With Modified Surface Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SmileDent Kft.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>S.G.S International Kft.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>SmileDent Kft.</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 observed medical device in this study were SGS P7D Dental implant. The device replaces&#xD;
        the lost tooth root, and provides support for the dental bridges and crowns, or overdenture&#xD;
        replacements. This medical device provides the opportunity to to replace partial or complete&#xD;
        missing teeth. Device material: Ti-6Al-4V Device surface protection: Corundum Blasting and&#xD;
  &#xD;
          1. phosphate surface treatment or&#xD;
  &#xD;
          2. hydroxylapatite surface treatment&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective, randomized, two-arms &quot;split-mouth&quot; study. The two arms: right and left of the&#xD;
        same mandible of the same volunteer with a different surface treatment, but every other&#xD;
        circumstances of the implants are the same, the same device with different surface materilas.&#xD;
  &#xD;
        &quot;A&quot; treatment: Implant with phosphate surface treatment is the lower one in the right side of&#xD;
        the jawbone, with hydroxylapatite surface treatment implant is placed in the left side of the&#xD;
        lower jaw. &quot;B&quot; treatment: Implant with phosphate surface treatment in the lower jaw on the&#xD;
        left side, the bottom is an implant with hydroxylapatite surface treatment is inserted into&#xD;
        the right side of the jaw bone&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 13, 2019</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>
      <intervention_model_description>two arms, split-mouth, randomized</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of OSSTELL ISQ score (for the degree of osseointegration indicator)</measure>
      <time_frame>36 months</time_frame>
      <description>Evaluation the difference between the two types surface treated implants osseointegration. For the measure is used the OSSTELL ISQ score.&#xD;
  results with the OSSTELL radio frequency device based on measurable stability values.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Volunteer-Quality of Life (OHIP Scale Scores)</measure>
      <time_frame>36 months</time_frame>
      <description>Establishing the effect of implantation and subsequent prosthetic intervention on the volunteers long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent). long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bone resorption measured mesially and distally in millimeters</measure>
      <time_frame>36 months</time_frame>
      <description>Determining the long-term difference between different implants in relation to bone erosion around the implant (radiological based on measurements).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Dental Implant</condition>
    <condition>Hydroxyapatite</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Implant with phosphate surface device in the right side of the lower jawbone, and the hydroxylapatite surface treatment implant is placed in the left side of the lower jaw.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Implant with phosphate surface device for the lower jaw on the left side, and the implant with hydroxylapatite surface treatment is inserted into the right side of the jawbone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>dental implant</intervention_name>
      <description>Dental implant surgery in the lower jawbone.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  complete lack of teeth in the lower jaw&#xD;
  &#xD;
            -  decision of the investigator: the patient is appropriate for implantation, clinical&#xD;
               conditions are sufficient (adequate soft tissue and bone conditions and occlusal&#xD;
               position;)&#xD;
  &#xD;
            -  the patient's consciousness is clear, understand the planned intervention.&#xD;
  &#xD;
            -  the patient communicates well with the examiner and is able to understand and comply&#xD;
               with the requirements of the test plan.&#xD;
  &#xD;
            -  witten informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  Women of childbearing potential, unless she uses effective birth control until the&#xD;
               completion of the final radiological examination, and for another 4 weeks after that.&#xD;
  &#xD;
            -  A disease (including, but not limited to metabolic, hematological, kidney, liver,&#xD;
               lung, neurological, endocrine, cardiac, infectious and gastrointestinal disease),&#xD;
               which -in the opinion of the investigator- significantly affects the health of the&#xD;
               examined person and/or exposes to an unacceptably high risk the person receiving the&#xD;
               implantation treatment.&#xD;
  &#xD;
            -  Malignant disease in the medical history in the preceding 24 months.&#xD;
  &#xD;
            -  Known HIV, hepatitis B or hepatitis C, or any other considered viral infection&#xD;
               relevant by the examiner known at the tome of randomization&#xD;
  &#xD;
            -  A medical or psychiatric illness which, in the opinion of the investigator, excludes&#xD;
               that the participant adheres to the protocol, or complete the study according to the&#xD;
               protocol.&#xD;
  &#xD;
            -  Participation in an other interventional clinical study within 6 months prior to&#xD;
               treatment.&#xD;
  &#xD;
            -  Known allergy to the implant or to the invetigational template or any of its&#xD;
               components.&#xD;
  &#xD;
            -  Limitation of mouth opening, which make unpossible to complete the procedure, based on&#xD;
               the opinion of the investigator&#xD;
  &#xD;
            -  Increased pharyngeal reflex, reduced ability to tolerate intraoral manipulation&#xD;
  &#xD;
            -  Radiotherapy, previous irradiation of the jawbones&#xD;
  &#xD;
            -  INR &gt; 2.5&#xD;
  &#xD;
            -  Immunosuppressed patient&#xD;
  &#xD;
            -  previous or current bisphosphonate treatment&#xD;
  &#xD;
            -  Known alcohol or drug abuse&#xD;
  &#xD;
            -  Heavy smoking (≥ 20 cigarettes per day, or another form of smoking, used in an&#xD;
               equivalent amount)&#xD;
  &#xD;
            -  Untreated periodontitis&#xD;
  &#xD;
            -  Local infection of the implant in the planned area&#xD;
  &#xD;
            -  Lack of dental hygiene, e.g. not removed radixes, plaque and calculus, or&#xD;
               radiologically detectable potential periapical focus (also in asymptomatic case )&#xD;
  &#xD;
            -  Insufficient or poor oral hygiene&#xD;
  &#xD;
            -  Transient infectious state, with or without fever&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Márk Antal, Dr. habil.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Szeged University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>SmileDent Kft.</name>
        <address>
          <city>Szeged</city>
          <zip>6724</zip>
          <country>Hungary</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hungary</country>
    </location_countries>
    <reference>
      <citation>Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11.</citation>
      <PMID>25503901</PMID>
    </reference>
    <reference>
      <citation>van Velzen FJ, Ofec R, Schulten EA, Ten Bruggenkate CM. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients. Clin Oral Implants Res. 2015 Oct;26(10):1121-8. doi: 10.1111/clr.12499. Epub 2014 Nov 5.</citation>
      <PMID>25370914</PMID>
    </reference>
    <reference>
      <citation>De Angelis F, Papi P, Mencio F, Rosella D, Di Carlo S, Pompa G. Implant survival and success rates in patients with risk factors: results from a long-term retrospective study with a 10 to 18 years follow-up. Eur Rev Med Pharmacol Sci. 2017 Feb;21(3):433-437.</citation>
      <PMID>28239830</PMID>
    </reference>
    <reference>
      <citation>Wang H, Eliaz N, Xiang Z, Hsu HP, Spector M, Hobbs LW. Early bone apposition in vivo on plasma-sprayed and electrochemically deposited hydroxyapatite coatings on titanium alloy. Biomaterials. 2006 Aug;27(23):4192-203. doi: 10.1016/j.biomaterials.2006.03.034. Epub 2006 Apr 18.</citation>
      <PMID>16618502</PMID>
    </reference>
    <reference>
      <citation>Eliaz N, Shmueli S, Shur I, Benayahu D, Aronov D, Rosenman G. The effect of surface treatment on the surface texture and contact angle of electrochemically deposited hydroxyapatite coating and on its interaction with bone-forming cells. Acta Biomater. 2009 Oct;5(8):3178-91. doi: 10.1016/j.actbio.2009.04.005. Epub 2009 Apr 10.</citation>
      <PMID>19409870</PMID>
    </reference>
    <reference>
      <citation>Eliaz N, Ritman-Hertz O, Aronov D, Weinberg E, Shenhar Y, Rosenman G, Weinreb M, Ron E. The effect of surface treatments on the adhesion of electrochemically deposited hydroxyapatite coating to titanium and on its interaction with cells and bacteria. J Mater Sci Mater Med. 2011 Jul;22(7):1741-52. doi: 10.1007/s10856-011-4355-y. Epub 2011 May 25.</citation>
      <PMID>21611792</PMID>
    </reference>
    <reference>
      <citation>Eliaz N, Kopelovitch W, Burstein L, Kobayashi E, Hanawa T. Electrochemical processes of nucleation and growth of calcium phosphate on titanium supported by real-time quartz crystal microbalance measurements and X-ray photoelectron spectroscopy analysis. J Biomed Mater Res A. 2009 Apr;89(1):270-80. doi: 10.1002/jbm.a.32129.</citation>
      <PMID>18563813</PMID>
    </reference>
    <reference>
      <citation>Eliaz N, Eliyahu M. Electrochemical processes of nucleation and growth of hydroxyapatite on titanium supported by real-time electrochemical atomic force microscopy. J Biomed Mater Res A. 2007 Mar 1;80(3):621-34. doi: 10.1002/jbm.a.30944.</citation>
      <PMID>17051536</PMID>
    </reference>
    <reference>
      <citation>Lakstein D, Kopelovitch W, Barkay Z, Bahaa M, Hendel D, Eliaz N. Enhanced osseointegration of grit-blasted, NaOH-treated and electrochemically hydroxyapatite-coated Ti-6Al-4V implants in rabbits. Acta Biomater. 2009 Jul;5(6):2258-69. doi: 10.1016/j.actbio.2009.01.033. Epub 2009 Feb 3.</citation>
      <PMID>19251497</PMID>
    </reference>
    <reference>
      <citation>Fernandez de Grado G, Keller L, Idoux-Gillet Y, Wagner Q, Musset AM, Benkirane-Jessel N, Bornert F, Offner D. Bone substitutes: a review of their characteristics, clinical use, and perspectives for large bone defects management. J Tissue Eng. 2018 Jun 4;9:2041731418776819. doi: 10.1177/2041731418776819. eCollection 2018 Jan-Dec.</citation>
      <PMID>29899969</PMID>
    </reference>
    <reference>
      <citation>Desjardins RP. Hydroxyapatite for alveolar ridge augmentation: indications and problems. J Prosthet Dent. 1985 Sep;54(3):374-83. doi: 10.1016/0022-3913(85)90556-6.</citation>
      <PMID>2999379</PMID>
    </reference>
    <reference>
      <citation>Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.</citation>
      <PMID>29608793</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06034171
  org study id: SM-SGS_001
  nct id: NCT06034171
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The observed medical device in this study were SGS P7D Dental implant. The device replaces
        the lost tooth root, and provides support for the dental bridges and crowns, or overdenture
        replacements. This medical device provides the opportunity to to replace partial or complete
        missing teeth. Device material: Ti-6Al-4V Device surface protection: Corundum Blasting and
  
          1. phosphate surface treatment or
  
          2. hydroxylapatite surface treatment
  A prospective, randomized, two-arms "split-mouth" study. The two arms: right and left of the
        same mandible of the same volunteer with a different surface treatment, but every other
        circumstances of the implants are the same, the same device with different surface materilas.
  
        "A" treatment: Implant with phosphate surface treatment is the lower one in the right side of
        the jawbone, with hydroxylapatite surface treatment implant is placed in the left side of the
        lower jaw. "B" treatment: Implant with phosphate surface treatment in the lower jaw on the
        left side, the bottom is an implant with hydroxylapatite surface treatment is inserted into
        the right side of the jaw bone
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: two arms, split-mouth, randomized
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Evaluation of OSSTELL ISQ score (for the degree of osseointegration indicator)
  time frame: 36 months
  description: Evaluation the difference between the two types surface treated implants osseointegration. For the measure is used the OSSTELL ISQ score.
  results with the OSSTELL radio frequency device based on measurable stability values.
  measure: Volunteer-Quality of Life (OHIP Scale Scores)
  time frame: 36 months
  description: Establishing the effect of implantation and subsequent prosthetic intervention on the volunteers long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent). long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent).
  measure: Bone resorption measured mesially and distally in millimeters
  time frame: 36 months
  description: Determining the long-term difference between different implants in relation to bone erosion around the implant (radiological based on measurements).
  arm group label: Group A
  arm group type: Experimental
  description: Implant with phosphate surface device in the right side of the lower jawbone, and the hydroxylapatite surface treatment implant is placed in the left side of the lower jaw.
  arm group label: Group B
  arm group type: Experimental
  description: Implant with phosphate surface device for the lower jaw on the left side, and the implant with hydroxylapatite surface treatment is inserted into the right side of the jawbone.
  intervention type: Device
  intervention name: dental implant
  description: Dental implant surgery in the lower jawbone.
  arm group label: Group A
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Márk Antal, Dr. habil.
  role: Principal Investigator
  affiliation: Szeged University
  facility: 
  country: Hungary
  citation: Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11.
  PMID: 25503901
  citation: van Velzen FJ, Ofec R, Schulten EA, Ten Bruggenkate CM. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients. Clin Oral Implants Res. 2015 Oct;26(10):1121-8. doi: 10.1111/clr.12499. Epub 2014 Nov 5.
  PMID: 25370914
  citation: De Angelis F, Papi P, Mencio F, Rosella D, Di Carlo S, Pompa G. Implant survival and success rates in patients with risk factors: results from a long-term retrospective study with a 10 to 18 years follow-up. Eur Rev Med Pharmacol Sci. 2017 Feb;21(3):433-437.
  PMID: 28239830
  citation: Wang H, Eliaz N, Xiang Z, Hsu HP, Spector M, Hobbs LW. Early bone apposition in vivo on plasma-sprayed and electrochemically deposited hydroxyapatite coatings on titanium alloy. Biomaterials. 2006 Aug;27(23):4192-203. doi: 10.1016/j.biomaterials.2006.03.034. Epub 2006 Apr 18.
  PMID: 16618502
  citation: Eliaz N, Shmueli S, Shur I, Benayahu D, Aronov D, Rosenman G. The effect of surface treatment on the surface texture and contact angle of electrochemically deposited hydroxyapatite coating and on its interaction with bone-forming cells. Acta Biomater. 2009 Oct;5(8):3178-91. doi: 10.1016/j.actbio.2009.04.005. Epub 2009 Apr 10.
  PMID: 19409870
  citation: Eliaz N, Ritman-Hertz O, Aronov D, Weinberg E, Shenhar Y, Rosenman G, Weinreb M, Ron E. The effect of surface treatments on the adhesion of electrochemically deposited hydroxyapatite coating to titanium and on its interaction with cells and bacteria. J Mater Sci Mater Med. 2011 Jul;22(7):1741-52. doi: 10.1007/s10856-011-4355-y. Epub 2011 May 25.
  PMID: 21611792
  citation: Eliaz N, Kopelovitch W, Burstein L, Kobayashi E, Hanawa T. Electrochemical processes of nucleation and growth of calcium phosphate on titanium supported by real-time quartz crystal microbalance measurements and X-ray photoelectron spectroscopy analysis. J Biomed Mater Res A. 2009 Apr;89(1):270-80. doi: 10.1002/jbm.a.32129.
  PMID: 18563813
  citation: Eliaz N, Eliyahu M. Electrochemical processes of nucleation and growth of hydroxyapatite on titanium supported by real-time electrochemical atomic force microscopy. J Biomed Mater Res A. 2007 Mar 1;80(3):621-34. doi: 10.1002/jbm.a.30944.
  PMID: 17051536
  citation: Lakstein D, Kopelovitch W, Barkay Z, Bahaa M, Hendel D, Eliaz N. Enhanced osseointegration of grit-blasted, NaOH-treated and electrochemically hydroxyapatite-coated Ti-6Al-4V implants in rabbits. Acta Biomater. 2009 Jul;5(6):2258-69. doi: 10.1016/j.actbio.2009.01.033. Epub 2009 Feb 3.
  PMID: 19251497
  citation: Fernandez de Grado G, Keller L, Idoux-Gillet Y, Wagner Q, Musset AM, Benkirane-Jessel N, Bornert F, Offner D. Bone substitutes: a review of their characteristics, clinical use, and perspectives for large bone defects management. J Tissue Eng. 2018 Jun 4;9:2041731418776819. doi: 10.1177/2041731418776819. eCollection 2018 Jan-Dec.
  PMID: 29899969
  citation: Desjardins RP. Hydroxyapatite for alveolar ridge augmentation: indications and problems. J Prosthet Dent. 1985 Sep;54(3):374-83. doi: 10.1016/0022-3913(85)90556-6.
  PMID: 2999379
  citation: Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
  PMID: 29608793
  responsible party type: Sponsor
  sharing ipd: No