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/NCT05973357</url>
    </required_header>
    <id_info>
      <org_study_id>1407</org_study_id>
      <nct_id>NCT05973357</nct_id>
    </id_info>
    <brief_title>The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss.</brief_title>
    <official_title>The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss: A Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multiple clinical studies have established high survival rates and tremendous predictability&#xD;
        of dental implant treatment. However, a pleasant esthetic outcome is the patient's primary&#xD;
        expectation regarding implants in the esthetic zone and several esthetic factors have been&#xD;
        evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue&#xD;
        level is considered to be one of the most important factors; Cosyn and co-workers reported&#xD;
        that among factors including soft tissue phenotype, the midfacial recession was associated&#xD;
        with the position of the implant .&#xD;
  &#xD;
        Therefore, subcrestal implant placement has been advocated as it has been associated with the&#xD;
        reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical&#xD;
        soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant&#xD;
        placement, implants will undergo unavoidable bone resorption by establishing sufficient&#xD;
        biologic protection. Another option was proposed by Linkevicius et al, who introduced the&#xD;
        subcrestal implant placement as a method to accommodate the problem of thin soft tissues.&#xD;
  &#xD;
        Research question:&#xD;
  &#xD;
        Does the placement of delayed implants with different vertical depth affect the marginal bone&#xD;
        loss with immediate provisionalization?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Preservation of crestal bone is crucial and must be prioritized from the onset of implant&#xD;
        placement. Adequate amount of peri-implant bone contributes to esthetic success and implant&#xD;
        stability. Crestal bone contributes to both esthetics and function. Resorption of crestal&#xD;
        bone is seen as loss of interproximal papillary support and gingival recession, which gives&#xD;
        way to peri-implantitis and compromises esthetics.&#xD;
  &#xD;
        With respect to the depth of insertion, implants can be placed at various levels in the bone,&#xD;
        in which affects the peri-implant tissues with the surrounding marginal bone. Therefore,&#xD;
        Placement of an implant in a deeper position with re¬spect to the bone crest (subcrestal&#xD;
        placement) has been suggested as a method that could contribute to main¬tain the periimplant&#xD;
        soft and hard tissues in comparison with crestal placement, though this affirmation is&#xD;
        sub¬ject to controversy.&#xD;
  &#xD;
        Rationale for conducting the research:&#xD;
  &#xD;
        Limiting the extent of peri-implant bone loss has been recognized for decades to be an&#xD;
        important aspect of long-term implant success, and stable peri-implant bone conditions play&#xD;
        an important role in maintaining esthetics.&#xD;
  &#xD;
        the opinion expressed widely in the scientific literature has been that subcrestal implant&#xD;
        placement leads to increased crestal bone resorption. However, clinical studies addressing&#xD;
        the implant placement depth in relation to crestal bone have been rare. Data on subcrestal&#xD;
        versus crestal placement have mostly come from animal studies. Even fewer data are available&#xD;
        regarding the effects of crestal versus subcrestal positioning of platform-switched implants.&#xD;
  &#xD;
        In a prospective research, Nagarajan et al. implanted equicrestal and subcrestal implants to&#xD;
        examine the crestal bone levels prior to loading. The crestal bone levels of the implants&#xD;
        placed equicrestally (1.31 mm 1.04 mm and 0.68 mm 1.08 mm on mesial and distal surfaces,&#xD;
        respectively) were higher than those of implants placed subcrestally (0.49 mm 0.49 mm and&#xD;
        0.025 mm 6.06 mm on mesial and distal surfaces, respectively), with a P value of crestal bone&#xD;
        level for both groups being 0.12 and 0. They came to the conclusion that there was no&#xD;
        difference in the amount of crestal bone loss prior to prosthetic loading between implants&#xD;
        placed at subcrestal and equicrestal levels. In this study eqi-crestal implant will be used&#xD;
        as a comparator but with immediate loading.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 20, 2025</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>Marginal bone loss</measure>
      <time_frame>1 year follow up</time_frame>
      <description>Crestal bone loss</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mid facial recession</measure>
      <time_frame>1 year follow up</time_frame>
      <description>Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth. Midfacial recession will be measured at 6, and 12 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The pink esthetic score</measure>
      <time_frame>1 year follow up</time_frame>
      <description>The pink esthetic score will be calculated on the parameters defined by. Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival Thickness</measure>
      <time_frame>1 year follow up</time_frame>
      <description>Gingival thickness will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth/implant until it contacts bone, at 3 different points; three readings mid-buccally at three different levels; 2mm, 4mm and 6mm apical to the gingival margin. The length of the part of the instrument that penetrates into the soft tissue is measured in mm using a digital caliper (Wiesner et al., 2010).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implant Survival</measure>
      <time_frame>1 year follow up</time_frame>
      <description>A binary outcome, the definition of implant success was based on the clinical and radiographic criteria;1) absence of clinically detectable implant mobility; 2) absence of pain or any subjective sensation; 3) absence of recurrent peri-implant infection; and 4) absence of persistent radiolucency around the implant after 12 months of loading</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative patient satisfaction</measure>
      <time_frame>1 year follow up</time_frame>
      <description>A 12-items questionnaire are self-reported by the patients after 12 months post-operative; 6 questions with with visual analoge scale from 1 to 10 with poorest score is not very satisfied equal 0 and optimum score is satisfied which equals 10. The another 6 questions is yes or no questions&#xD;
  This questions measure patient's acceptability and esthetics satisfaction</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Dental Implant Failed</condition>
    <condition>Implant Site Reaction</condition>
    <arm_group>
      <arm_group_label>Sub-crestal group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Equi-crestal grouo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receiving delayed implant placed equi-crestal level with immediate provisionalization</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Sub-crestal implant</intervention_name>
      <description>Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization</description>
      <arm_group_label>Sub-crestal group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Equi-crestal implant</intervention_name>
      <description>Patients receiving delayed implant placed equi-crestal level with immediate provisionalization</description>
      <arm_group_label>Equi-crestal grouo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ● Patients with single missing upper anterior or premolar teeth&#xD;
  &#xD;
                 -  Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6mm&#xD;
  &#xD;
                 -  Patients with healthy systemic conditions.&#xD;
  &#xD;
                 -  Patients older than 18 years.&#xD;
  &#xD;
                 -  Good oral hygiene.&#xD;
  &#xD;
                 -  Accepts one year follow-up period (cooperative patients).&#xD;
  &#xD;
                 -  The patient provides informed consent.&#xD;
  &#xD;
                 -  Adequate Inter-arch space for implant placement.&#xD;
  &#xD;
                 -  Favorable occlusion (no traumatic occlusion).&#xD;
  &#xD;
                 -  Absence of allergy to the prescribed medications.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ● Patients with inadequate bone volume and/ or quality&#xD;
  &#xD;
                 -  Patients with local root remnants&#xD;
  &#xD;
                 -  Patients with inadequate wound healing&#xD;
  &#xD;
                 -  Patients with signs of acute infection related to the area of interest.&#xD;
  &#xD;
                 -  Patients with habits that may jeopardize the implant longevity and affect the&#xD;
                    results of the study such as parafunctional habits (Lobbezoo et al., 2006).&#xD;
  &#xD;
                 -  Heavy smokers patients (more than 10 cigarettes per day) (Lambert, Morris and&#xD;
                    Ochi, 2000).&#xD;
  &#xD;
                 -  Metabolic diseases such as diabetes or hyperthyroidism as well as systemic&#xD;
                    medications such as chemotherapy or bisphosphonates&#xD;
  &#xD;
                 -  Pregnant or nursing women.&#xD;
  &#xD;
                 -  Uncooperative patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>RWGWanis</investigator_full_name>
      <investigator_title>Assistant Lecturer</investigator_title>
    </responsible_party>
    <keyword>Delayed Implant</keyword>
    <keyword>Immediate loading</keyword>
    <keyword>Temporization</keyword>
    <keyword>provisionalization</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05973357
  org study id: 1407
  nct id: NCT05973357
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Multiple clinical studies have established high survival rates and tremendous predictability
        of dental implant treatment. However, a pleasant esthetic outcome is the patient's primary
        expectation regarding implants in the esthetic zone and several esthetic factors have been
        evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue
        level is considered to be one of the most important factors; Cosyn and co-workers reported
        that among factors including soft tissue phenotype, the midfacial recession was associated
        with the position of the implant .
  
        Therefore, subcrestal implant placement has been advocated as it has been associated with the
        reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical
        soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant
        placement, implants will undergo unavoidable bone resorption by establishing sufficient
        biologic protection. Another option was proposed by Linkevicius et al, who introduced the
        subcrestal implant placement as a method to accommodate the problem of thin soft tissues.
  
        Research question:
  
        Does the placement of delayed implants with different vertical depth affect the marginal bone
        loss with immediate provisionalization?
  Preservation of crestal bone is crucial and must be prioritized from the onset of implant
        placement. Adequate amount of peri-implant bone contributes to esthetic success and implant
        stability. Crestal bone contributes to both esthetics and function. Resorption of crestal
        bone is seen as loss of interproximal papillary support and gingival recession, which gives
        way to peri-implantitis and compromises esthetics.
  
        With respect to the depth of insertion, implants can be placed at various levels in the bone,
        in which affects the peri-implant tissues with the surrounding marginal bone. Therefore,
        Placement of an implant in a deeper position with re¬spect to the bone crest (subcrestal
        placement) has been suggested as a method that could contribute to main¬tain the periimplant
        soft and hard tissues in comparison with crestal placement, though this affirmation is
        sub¬ject to controversy.
  
        Rationale for conducting the research:
  
        Limiting the extent of peri-implant bone loss has been recognized for decades to be an
        important aspect of long-term implant success, and stable peri-implant bone conditions play
        an important role in maintaining esthetics.
  
        the opinion expressed widely in the scientific literature has been that subcrestal implant
        placement leads to increased crestal bone resorption. However, clinical studies addressing
        the implant placement depth in relation to crestal bone have been rare. Data on subcrestal
        versus crestal placement have mostly come from animal studies. Even fewer data are available
        regarding the effects of crestal versus subcrestal positioning of platform-switched implants.
  
        In a prospective research, Nagarajan et al. implanted equicrestal and subcrestal implants to
        examine the crestal bone levels prior to loading. The crestal bone levels of the implants
        placed equicrestally (1.31 mm 1.04 mm and 0.68 mm 1.08 mm on mesial and distal surfaces,
        respectively) were higher than those of implants placed subcrestally (0.49 mm 0.49 mm and
        0.025 mm 6.06 mm on mesial and distal surfaces, respectively), with a P value of crestal bone
        level for both groups being 0.12 and 0. They came to the conclusion that there was no
        difference in the amount of crestal bone loss prior to prosthetic loading between implants
        placed at subcrestal and equicrestal levels. In this study eqi-crestal implant will be used
        as a comparator but with immediate loading.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Marginal bone loss
  time frame: 1 year follow up
  description: Crestal bone loss
  measure: Mid facial recession
  time frame: 1 year follow up
  description: Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth. Midfacial recession will be measured at 6, and 12 months.
  measure: The pink esthetic score
  time frame: 1 year follow up
  description: The pink esthetic score will be calculated on the parameters defined by. Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.
  measure: Gingival Thickness
  time frame: 1 year follow up
  description: Gingival thickness will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth/implant until it contacts bone, at 3 different points; three readings mid-buccally at three different levels; 2mm, 4mm and 6mm apical to the gingival margin. The length of the part of the instrument that penetrates into the soft tissue is measured in mm using a digital caliper (Wiesner et al., 2010).
  measure: Implant Survival
  time frame: 1 year follow up
  description: A binary outcome, the definition of implant success was based on the clinical and radiographic criteria;1) absence of clinically detectable implant mobility; 2) absence of pain or any subjective sensation; 3) absence of recurrent peri-implant infection; and 4) absence of persistent radiolucency around the implant after 12 months of loading
  measure: Post-operative patient satisfaction
  time frame: 1 year follow up
  description: A 12-items questionnaire are self-reported by the patients after 12 months post-operative; 6 questions with with visual analoge scale from 1 to 10 with poorest score is not very satisfied equal 0 and optimum score is satisfied which equals 10. The another 6 questions is yes or no questions
  This questions measure patient's acceptability and esthetics satisfaction
  arm group label: Sub-crestal group
  arm group type: Experimental
  description: Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization
  arm group label: Equi-crestal grouo
  arm group type: Experimental
  description: Patients receiving delayed implant placed equi-crestal level with immediate provisionalization
  intervention type: Procedure
  intervention name: Sub-crestal implant
  description: Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization
  arm group label: Sub-crestal group
  intervention type: Procedure
  intervention name: Equi-crestal implant
  description: Patients receiving delayed implant placed equi-crestal level with immediate provisionalization
  arm group label: Equi-crestal grouo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: RWGWanis
  investigator title: Assistant Lecturer
  sharing ipd: Undecided