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/NCT05975814</url>
    </required_header>
    <id_info>
      <org_study_id>MIS-CONCAVE</org_study_id>
      <nct_id>NCT05975814</nct_id>
    </id_info>
    <brief_title>The Effect of Concave Healing Abutment on Soft Tissue Healing</brief_title>
    <official_title>Effect of the Shape of the Healing Abutment on Soft Tissue Healing. A Randomized Clinical Study Involving an Enhanced Digital Superposition Methodology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MIS Implant Technologies, Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Charite University, Berlin, Germany</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sachsen Praxen Zahnarztpraxis</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>MIS Implant Technologies, Ltd</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>
        The aim of this study is to document the relevance of the concave abutment to form more&#xD;
        gingiva when compared to the straight abutment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Standard clinical and radiographic examination will assess the need for implant therapy, the&#xD;
        number of implants and the rehabilitation type. The pre-operative skeletal data will be&#xD;
        observed with a 3D cone-beam computed tomographic examination (Cranex 3D, Soredex, Tuusula,&#xD;
        Finland). On implantation day just before surgery, an initial intra-oral scan (TRIOS3,&#xD;
        3Shape, Copenhagen, Denmark) will be taken (IOS#0) to provide the baseline of the soft tissue&#xD;
        outline. The surgical procedure will involve a crestal incision with 2 lateral discharge&#xD;
        incisions; a full flap will be raised and the periosteum will be carefully separated from the&#xD;
        cortical bone. The implant osteotomy will be prepared by executing the drilling sequence&#xD;
        recommended by the manufacturer according to bone density; the final single-use drill that&#xD;
        comes with each implant will be implemented on top of the drills when relevant. SEVEN (MIS) Ø&#xD;
        4.2 mm implants with an internal hex connection of appropriate length will be placed&#xD;
        according to a 1-stage surgical protocol. They will receive a Ø 4.8 x 6 mm wide abutment,&#xD;
        either straight or concave, according to the randomization. To anticipate early bone loss the&#xD;
        implants will be seated slightly in a subcrestal position.&#xD;
  &#xD;
        For single crown rehabilitations, a coin randomization will be performed to determine the&#xD;
        abutment type, straight or concave; for plural restorations, randomization will start from&#xD;
        the most distal implant. Height of all healing abutments will be 6 mm because this item&#xD;
        provides the largest available mismatch concavity, 0.6 mm, compared to the straight abutment.&#xD;
        After implant and abutment placement, the flap and periosteum will be reclined and sutured&#xD;
        with single discontinued sutures around the abutments without tension. The patients will&#xD;
        receive antibiotics (875/125 mg of Amoxicillin/Clavulanic acid, 3/d for 7 days; in case of&#xD;
        penicillin allergy, 300 mg of Clindamycin every 6 h for 7 days) and analgesic&#xD;
        anti-inflammatory treatment (600 mg Ibuprofen 3/d); rinsing with Chlorhexidine (0.12%)&#xD;
        (Dentaid® PerioAid 0.12%) will be prescribed 2/d for 2 weeks. Sutures will be removed after&#xD;
        10 days (Cacaci et al., 2021). After a transmucosal soft tissue healing period of 6-8 weeks,&#xD;
        the healed sites will be scanned (IOS#1).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2021</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>clinical study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>each implant receives either a straight or a concave abutment. The patient is not aware of the type of abutment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Thickness of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment</measure>
      <time_frame>end of healing, 6-8 weeks after implant surgery</time_frame>
      <description>The thickness of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Height of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment</measure>
      <time_frame>end of healing, 6-8 weeks after implant surgery</time_frame>
      <description>The height of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Dental Implant Therapy</condition>
    <arm_group>
      <arm_group_label>concave abutment vs. straight abutment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After implant is placed a randomization will determine if the implant receives a straight or a concave abutment. If a patient requires 2 implants, one of them will be straight and the other will be concave. A patient can therefore have both abutments.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>dental implant</intervention_name>
      <description>dental implants are placed as usual and require a healing abutment. Abutments can be straight or concave, both are equally available on the market.</description>
      <arm_group_label>concave abutment vs. straight abutment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          a) patients older than 18 years in need of implant therapy in the posterior area of the&#xD;
          mandible and maxilla, b) good general/systemic health (ASA type I, II), c) patients who&#xD;
          committed to attend all visits of the study, d) placement of a Ø 4.2 mm implant without&#xD;
          requiring bone augmentation, e) adequate oral hygiene with FMPS (full mouth plaque score) &lt;&#xD;
          15% before surgery, f) absence of uncontrolled periodontal disease, g) agreeing to sign an&#xD;
          informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          a) patients with a contributing medical history in which any surgery, disease, condition,&#xD;
          or medication susceptible to compromise the healing of soft and hard tissues (e.g.&#xD;
          non-controlled diabetes), b) liver function disorder, c) immune system disease, d)&#xD;
          immunosuppressant drugs, e) toxic habits other than smoking that might compromise or affect&#xD;
          healing, f) patients who have undergone chemotherapy or radiation treatment during the&#xD;
          previous 5 years comprising the head and neck area, g) corticosteroids therapy or any other&#xD;
          medication that could influence postoperative healing and/or osseointegration, h)&#xD;
          bisphosphonate or Denosumab therapy (Prolia®), i) sites that underwent or require a&#xD;
          horizontal or vertical bone regeneration procedure, j) inability or unwillingness to attend&#xD;
          follow-up visits, k) patients unwilling to sign an informed consent form.&#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>Rasmus Sperber, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sachen Praxen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thilo Damaskos, Dr</last_name>
      <phone>+41 170 228 2816</phone>
      <email>thilo.damaskos@gmx.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rasmus Sperber, Dr</last_name>
      <phone>+49 1511 6164966</phone>
      <email>rasmus.sperber@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mis Implants Technologies Ltd.</name>
        <address>
          <city>Misgav</city>
          <zip>2015600</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michal Malka</last_name>
        <phone>+972547257128</phone>
        <email>michal.malka@dentsplysirona.com</email>
      </contact>
      <contact_backup>
        <last_name>Serge Szmukler, Dr</last_name>
        <phone>+972537085454</phone>
        <email>serge.szmukler@dentsplysirona.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <results_reference>
      <citation>Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.</citation>
      <PMID>34551159</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dental implants</keyword>
    <keyword>concave abutments</keyword>
    <keyword>intra-oral scans</keyword>
    <keyword>CBCT</keyword>
    <keyword>soft tissue thickness</keyword>
    <keyword>randomized clinical study</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/NCT05975814
  org study id: MIS-CONCAVE
  nct id: NCT05975814
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to document the relevance of the concave abutment to form more
        gingiva when compared to the straight abutment.
  Standard clinical and radiographic examination will assess the need for implant therapy, the
        number of implants and the rehabilitation type. The pre-operative skeletal data will be
        observed with a 3D cone-beam computed tomographic examination (Cranex 3D, Soredex, Tuusula,
        Finland). On implantation day just before surgery, an initial intra-oral scan (TRIOS3,
        3Shape, Copenhagen, Denmark) will be taken (IOS#0) to provide the baseline of the soft tissue
        outline. The surgical procedure will involve a crestal incision with 2 lateral discharge
        incisions; a full flap will be raised and the periosteum will be carefully separated from the
        cortical bone. The implant osteotomy will be prepared by executing the drilling sequence
        recommended by the manufacturer according to bone density; the final single-use drill that
        comes with each implant will be implemented on top of the drills when relevant. SEVEN (MIS) Ø
        4.2 mm implants with an internal hex connection of appropriate length will be placed
        according to a 1-stage surgical protocol. They will receive a Ø 4.8 x 6 mm wide abutment,
        either straight or concave, according to the randomization. To anticipate early bone loss the
        implants will be seated slightly in a subcrestal position.
  
        For single crown rehabilitations, a coin randomization will be performed to determine the
        abutment type, straight or concave; for plural restorations, randomization will start from
        the most distal implant. Height of all healing abutments will be 6 mm because this item
        provides the largest available mismatch concavity, 0.6 mm, compared to the straight abutment.
        After implant and abutment placement, the flap and periosteum will be reclined and sutured
        with single discontinued sutures around the abutments without tension. The patients will
        receive antibiotics (875/125 mg of Amoxicillin/Clavulanic acid, 3/d for 7 days; in case of
        penicillin allergy, 300 mg of Clindamycin every 6 h for 7 days) and analgesic
        anti-inflammatory treatment (600 mg Ibuprofen 3/d); rinsing with Chlorhexidine (0.12%)
        (Dentaid® PerioAid 0.12%) will be prescribed 2/d for 2 weeks. Sutures will be removed after
        10 days (Cacaci et al., 2021). After a transmucosal soft tissue healing period of 6-8 weeks,
        the healed sites will be scanned (IOS#1).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: clinical study
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: each implant receives either a straight or a concave abutment. The patient is not aware of the type of abutment.
  measure: Thickness of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment
  time frame: end of healing, 6-8 weeks after implant surgery
  description: The thickness of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides
  measure: Height of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment
  time frame: end of healing, 6-8 weeks after implant surgery
  description: The height of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides
  arm group label: concave abutment vs. straight abutment
  arm group type: Experimental
  description: After implant is placed a randomization will determine if the implant receives a straight or a concave abutment. If a patient requires 2 implants, one of them will be straight and the other will be concave. A patient can therefore have both abutments.
  intervention type: Device
  intervention name: dental implant
  description: dental implants are placed as usual and require a healing abutment. Abutments can be straight or concave, both are equally available on the market.
  arm group label: concave abutment vs. straight abutment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Rasmus Sperber, Dr
  role: Principal Investigator
  affiliation: Sachen Praxen
  last name: Thilo Damaskos, Dr
  phone: +41 170 228 2816
  email: thilo.damaskos@gmx.de
  last name: Rasmus Sperber, Dr
  phone: +49 1511 6164966
  email: rasmus.sperber@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Israel
  citation: Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.
  PMID: 34551159
  responsible party type: Sponsor
  sharing ipd: No