<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/NCT03837275</url>
  </required_header>
  <id_info>
    <org_study_id>oral surgery 14285</org_study_id>
    <nct_id>NCT03837275</nct_id>
  </id_info>
  <brief_title>Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique Versus Closed Maxillary Sinus Floor Elevation.</brief_title>
  <acronym>humsfe</acronym>
  <official_title>Comparative Study of Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) Versus Closed Maxillary Sinus Floor Elevation.</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>
      Placing implants in the posterior maxillary area has the drawback of working with scarce,&#xD;
      poor quality bone in a significant percentage of cases. Numerous advanced surgical techniques&#xD;
      have been developed to overcome the difficulties associated with these limitations.&#xD;
      Subsequent to reports on the elevation of the maxillary sinus through the lateral approach,&#xD;
      there were reports on the use of the crestal approach, which is less aggressive but requires&#xD;
      a minimal amount of bone. Furthermore, it is more sensitive to operator technique, as the&#xD;
      integrity of the sinus membrane is checked indirectly. The main advantage of this new&#xD;
      technique, Intralift, is that it does not require a minimum amount of crestal bone (indeed,&#xD;
      the smaller the width of the crestal bone, the better this technique is performed). The&#xD;
      possibility of damage to the sinus membrane is minimised by using ultrasound based&#xD;
      hydrodynamic pressure to lift it, while applying a very non-aggressive crestal approach.&#xD;
      Conclusions: We believe that this technique is an advance in the search for less traumatic&#xD;
      and aggressive techniques, which is the hallmark of current surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An essential condition for success in dental implant treatment is the amount and quality of&#xD;
      bone in the area on which we decide to place the implant after careful diagnosis and&#xD;
      planning. The posterior area of the upper jaw has anatomical features that make it unique&#xD;
      compared to other areas, mainly due to the presence of the maxillary sinus. After tooth loss&#xD;
      there is progressive bone resorption, combined with sinus pneumatization and loss of bone&#xD;
      height and quality, which greatly hinders the placement of dental implant.&#xD;
&#xD;
      Sinus lifting procedures are performed routinely to provide the required height of proper and&#xD;
      stable bone tissue around the dental implants to be inserted. The surgical technique of&#xD;
      maxillary sinus Schneiderian membrane (MSSM) lifting with immediate/simultaneous installation&#xD;
      of dental implants, generally results in significant bone formation. The recently reported&#xD;
      graftless MSSM elevation procedure and the subsequent augmentation of bone have greatly&#xD;
      changed our perspective of bone neoformation potential. The blood clot formed under the&#xD;
      lifted MSSM appears to be of critical importance in bone neoformation potential, precluding&#xD;
      the need for exogenous graft materials In elevation with the rotary technique, the main&#xD;
      intraoperative complication is perforation of Schneider's membrane, which is observed in&#xD;
      between 10-35% of all such operations, and which usually occurs in the osteotomy drilling&#xD;
      phase while preparing the window for access to the sinus With the purpose of reducing the&#xD;
      risk of perforating Schneider's membrane, vestibule osteotomy using ultrasound has been&#xD;
      proposed, as this reduces the risk of soft tissue damage and percentage membrane perforation&#xD;
      to 7%. Some studies in the literature are preliminary descriptions of the technique, while&#xD;
      others present isolated cases and others in turn report case series - no significant&#xD;
      differences being observed between the two techniques The selective cutting is the result of&#xD;
      the limited amplitude. At this amplitude, only mineralized tissue will be cut, because soft&#xD;
      tissue requires frequencies of greater than 50 kHz. Therefore, the use of piezoelectric&#xD;
      instruments will reduce the risk of nerve damage. The reduction of overheating is explained&#xD;
      by the generation of a cavitation effect in the irrigation solution due to the mechanical&#xD;
      micro-movements at a frequency of approximately 25-30 kHz. This also accounts for reduced&#xD;
      bleeding, which means better surgical visibility and increased safety.&#xD;
&#xD;
      Perforation of the Schneiderian membrane doubles the risk for the incidence of sinusitis or&#xD;
      infection. Therefore, it is of great importance that any perforation should be avoided. The&#xD;
      use of the piezoelectric device reduces the frequency of membrane perforation among surgeons&#xD;
      with limited experience. Specific tips can even decrease the risk of accidental or iatrogenic&#xD;
      perforations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>it is randomized clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>double ( participant- outcome assessor) single blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>gained bone height</measure>
    <time_frame>3 month</time_frame>
    <description>measured in millimeters by cone beam computed tomography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Dental Implant</condition>
  <arm_group>
    <arm_group_label>humsfe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>closed sinus lift</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>transcrestal maxilllary sinus floor elevation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique</intervention_name>
    <description>Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) and implant placement</description>
    <arm_group_label>humsfe</arm_group_label>
    <other_name>intralift technique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>closed maxillary sinus lift</intervention_name>
    <description>transdcrestal sinus lift and immediate implant placment</description>
    <arm_group_label>closed sinus lift</arm_group_label>
    <other_name>transcrestal sinus lift</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        The following inclusion criteria will be established: (Llopet et al., 2014) Inclusion&#xD;
        criteria: edentulous maxilla in premolar-molar areas with a residual ridge height of 9 mm&#xD;
        or less.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria: sinuses with septa in the operated area, polyps, sequelae of&#xD;
             fistulas or fractures.&#xD;
&#xD;
        Cases for current study will be selected free from local pathosis. Patients will be free&#xD;
        from any systemic disease that could affect their reparative power.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients are eligible for implant placement older than 18 years old</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed S El Hadidy, phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Basma Ga Mousa, phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alaa Sh Emara, phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mostafa A El Masry, msc</last_name>
    <phone>00201221953838</phone>
    <email>mostafa.elmasry@hotmail.com</email>
  </overall_contact>
  <reference>
    <citation>Velazquez-Cayon R, Romero-Ruiz MM, Torres-Lagares D, Perez-Dorao B, Wainwright M, Abalos-Labruzzi C, Gutierrez-Perez JL. Hydrodynamic ultrasonic maxillary sinus lift: review of a new technique and presentation of a clinical case. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e271-5. doi: 10.4317/medoral.17430.</citation>
    <PMID>22143696</PMID>
  </reference>
  <reference>
    <citation>Barone A, Santini S, Sbordone L, Crespi R, Covani U. A clinical study of the outcomes and complications associated with maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):81-5.</citation>
    <PMID>16519185</PMID>
  </reference>
  <reference>
    <citation>Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP. Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent. 2005 Dec;25(6):543-9.</citation>
    <PMID>16353529</PMID>
  </reference>
  <reference>
    <citation>Chipaila N, Marini R, Sfasciotti GL, Cielo A, Bonanome L, Monaco A. Graftless sinus augmentation technique with contextual placement of implants: a case report. J Med Case Rep. 2014 Dec 17;8:437. doi: 10.1186/1752-1947-8-437.</citation>
    <PMID>25515949</PMID>
  </reference>
  <reference>
    <citation>Llopet J, Montaudon M, Guillaud E, Ella B. Comparison of 2 crestal sinus floor lift techniques performed on human cadavers. Implant Dent. 2014 Oct;23(5):626-32. doi: 10.1097/ID.0000000000000143.</citation>
    <PMID>25192160</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>mostafa elmasry</investigator_full_name>
    <investigator_title>teaching assistant</investigator_title>
  </responsible_party>
  <keyword>intralift</keyword>
  <keyword>maxillery sinus lift</keyword>
  <keyword>hydrodynamic ultrasonic</keyword>
  <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/NCT03837275
org study id: oral surgery 14285
nct id: NCT03837275
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Placing implants in the posterior maxillary area has the drawback of working with scarce,
      poor quality bone in a significant percentage of cases. Numerous advanced surgical techniques
      have been developed to overcome the difficulties associated with these limitations.
      Subsequent to reports on the elevation of the maxillary sinus through the lateral approach,
      there were reports on the use of the crestal approach, which is less aggressive but requires
      a minimal amount of bone. Furthermore, it is more sensitive to operator technique, as the
      integrity of the sinus membrane is checked indirectly. The main advantage of this new
      technique, Intralift, is that it does not require a minimum amount of crestal bone (indeed,
      the smaller the width of the crestal bone, the better this technique is performed). The
      possibility of damage to the sinus membrane is minimised by using ultrasound based
      hydrodynamic pressure to lift it, while applying a very non-aggressive crestal approach.
      Conclusions: We believe that this technique is an advance in the search for less traumatic
      and aggressive techniques, which is the hallmark of current surgery.
An essential condition for success in dental implant treatment is the amount and quality of
      bone in the area on which we decide to place the implant after careful diagnosis and
      planning. The posterior area of the upper jaw has anatomical features that make it unique
      compared to other areas, mainly due to the presence of the maxillary sinus. After tooth loss
      there is progressive bone resorption, combined with sinus pneumatization and loss of bone
      height and quality, which greatly hinders the placement of dental implant.

      Sinus lifting procedures are performed routinely to provide the required height of proper and
      stable bone tissue around the dental implants to be inserted. The surgical technique of
      maxillary sinus Schneiderian membrane (MSSM) lifting with immediate/simultaneous installation
      of dental implants, generally results in significant bone formation. The recently reported
      graftless MSSM elevation procedure and the subsequent augmentation of bone have greatly
      changed our perspective of bone neoformation potential. The blood clot formed under the
      lifted MSSM appears to be of critical importance in bone neoformation potential, precluding
      the need for exogenous graft materials In elevation with the rotary technique, the main
      intraoperative complication is perforation of Schneider's membrane, which is observed in
      between 10-35% of all such operations, and which usually occurs in the osteotomy drilling
      phase while preparing the window for access to the sinus With the purpose of reducing the
      risk of perforating Schneider's membrane, vestibule osteotomy using ultrasound has been
      proposed, as this reduces the risk of soft tissue damage and percentage membrane perforation
      to 7%. Some studies in the literature are preliminary descriptions of the technique, while
      others present isolated cases and others in turn report case series - no significant
      differences being observed between the two techniques The selective cutting is the result of
      the limited amplitude. At this amplitude, only mineralized tissue will be cut, because soft
      tissue requires frequencies of greater than 50 kHz. Therefore, the use of piezoelectric
      instruments will reduce the risk of nerve damage. The reduction of overheating is explained
      by the generation of a cavitation effect in the irrigation solution due to the mechanical
      micro-movements at a frequency of approximately 25-30 kHz. This also accounts for reduced
      bleeding, which means better surgical visibility and increased safety.

      Perforation of the Schneiderian membrane doubles the risk for the incidence of sinusitis or
      infection. Therefore, it is of great importance that any perforation should be avoided. The
      use of the piezoelectric device reduces the frequency of membrane perforation among surgeons
      with limited experience. Specific tips can even decrease the risk of accidental or iatrogenic
      perforations.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: it is randomized clinical trial.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double ( participant- outcome assessor) single blinded
measure: gained bone height
time frame: 3 month
description: measured in millimeters by cone beam computed tomography
arm group label: humsfe
arm group type: Experimental
description: Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique)
arm group label: closed sinus lift
arm group type: Active Comparator
description: transcrestal maxilllary sinus floor elevation
intervention type: Procedure
intervention name: Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique
description: Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) and implant placement
arm group label: humsfe
other name: intralift technique
intervention type: Procedure
intervention name: closed maxillary sinus lift
description: transdcrestal sinus lift and immediate implant placment
arm group label: closed sinus lift
other name: transcrestal sinus lift
criteria: 
gender: All
gender based: Yes
gender description: patients are eligible for implant placement older than 18 years old
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed S El Hadidy, phd
role: Study Chair
affiliation: Cairo University
last name: Basma Ga Mousa, phd
role: Study Chair
affiliation: Cairo University
last name: Alaa Sh Emara, phd
role: Study Chair
affiliation: Cairo University
last name: Mostafa A El Masry, msc
phone: 00201221953838
email: mostafa.elmasry@hotmail.com
citation: Velazquez-Cayon R, Romero-Ruiz MM, Torres-Lagares D, Perez-Dorao B, Wainwright M, Abalos-Labruzzi C, Gutierrez-Perez JL. Hydrodynamic ultrasonic maxillary sinus lift: review of a new technique and presentation of a clinical case. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e271-5. doi: 10.4317/medoral.17430.
PMID: 22143696
citation: Barone A, Santini S, Sbordone L, Crespi R, Covani U. A clinical study of the outcomes and complications associated with maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):81-5.
PMID: 16519185
citation: Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP. Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent. 2005 Dec;25(6):543-9.
PMID: 16353529
citation: Chipaila N, Marini R, Sfasciotti GL, Cielo A, Bonanome L, Monaco A. Graftless sinus augmentation technique with contextual placement of implants: a case report. J Med Case Rep. 2014 Dec 17;8:437. doi: 10.1186/1752-1947-8-437.
PMID: 25515949
citation: Llopet J, Montaudon M, Guillaud E, Ella B. Comparison of 2 crestal sinus floor lift techniques performed on human cadavers. Implant Dent. 2014 Oct;23(5):626-32. doi: 10.1097/ID.0000000000000143.
PMID: 25192160
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: mostafa elmasry
investigator title: teaching assistant
sharing ipd: Undecided
ipd description: I will check with my study chair