<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/NCT04481867</url>
  </required_header>
  <id_info>
    <org_study_id>sinus lift densah bur</org_study_id>
    <nct_id>NCT04481867</nct_id>
  </id_info>
  <brief_title>Patient Perception and Radiographic Assessment of Sinus Lifting Procedure</brief_title>
  <official_title>Patient Perception and Radiographic Assessment of Sinus Lifting Procedure Using Densah Bur Versus Ostetome . A Randomized 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>
      This study aimed to evaluate the clinical complications that might be presented with&#xD;
      osteotome and densah burs, as well as to assess the new bone generated at 6 months&#xD;
      post-operatively using CBCT. The study hypothesis was that densah bur would show comparable&#xD;
      results to osteotome-mediated sinus lifting&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maxillary posterior edentulous area rehabilitation with implants is usually not an easy&#xD;
      procedure and is considered a challenge to many prosthodontists. This is due to&#xD;
      pneumatization of the maxillary sinus, poor bone density and volume, and difficult&#xD;
      accessibility of this area. After tooth loss, the maxillary sinus tends to enlarge into the&#xD;
      remaining residual ridge because of poor bone density and lack of functional stimulation by&#xD;
      teeth.1 Rehabilitation with dental implants in the maxillary posterior area depends on the&#xD;
      quantity and quality of bone available for implant placement. In order to place the implant&#xD;
      in the best prosthetic position, regenerative surgical techniques are usually essential to&#xD;
      correct the initial anatomical situation.2 Summer in 1994 introduced a less invasive&#xD;
      technique than the lateral approach for sinus floor elevation, called the closed sinus&#xD;
      lifting. Summer classified it in to osteotome sinus floor elevation and bone added osteotome&#xD;
      sinus floor elevation. Osteotome depends on condensing the bone in implant bed site and&#xD;
      pushing it laterally and upward, which raises the sinus floor. Although being successful and&#xD;
      non-invasive, Summer's technique showed several surgical problems as heat generation-induced&#xD;
      necrosis if not well irrigated, and delayed implant secondary stability, as well as some&#xD;
      patient-related drawbacks as headache and vertigo.3 Fortunately, in 2014 Salah Huwais&#xD;
      introduced new burs called densah burs that help preservation of bone health by condensing&#xD;
      bone rather than removing it. Accordingly, this process was labeled osseodensification. In&#xD;
      the past few years since the introduction of densah burs, limited number of studies evaluated&#xD;
      its efficiency as well as patient perception to the procedure. 4 It is well established that&#xD;
      cone beam computed tomography (CBCT) gives more profound and accurate assessment of pre- and&#xD;
      post-operative implant sites. However, a meta-analysis was published in 2018 showed that most&#xD;
      previous studies on lifting procedures used conventional 2D techniques, and very few applied&#xD;
      CBCT as the diagnostic modality. This heterogeneity highly affected the quality of evidence&#xD;
      retrieved. 5 This study aimed to validate the clinical complications that might be presented&#xD;
      with osteotome and densah burs, as well as to assess the new bone generated at 6 months&#xD;
      post-operatively using CBCT. The study hypothesis was that densah bur would show comparable&#xD;
      results to osteotome-mediated sinus lifting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 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>randomized control trail</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical patient perception</measure>
    <time_frame>7 days postoperative</time_frame>
    <description>assessment with Health-Related Quality of Life (HRQOL) questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radio-graphic (CBCT) assessment</measure>
    <time_frame>preoperative and 6 month postoperative</time_frame>
    <description>New bone length around the implant ,in millimetre</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Dental Implant Failed</condition>
  <arm_group>
    <arm_group_label>intervention arm :densah bur group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>at the maxillary molar area for implant placement ,,just after making initial drilling perforation close to the sinus floor, the direction of the drill is reversed and the cutting speed is raised to 1200 rpm, then 2 successive densah burs are used to elevate sinus membrane 2 mm and to prepare implant hole to the selected implant size .for both groups the selected implant size, 4.2 mm width and 10 mm. length</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group :osteotome group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>at the maxillary molar area for implant placement .a set of concave osteotomes with different dimensions sequentially used to widen the osteotomy site by surgical mallet. Osteotome 2.5 mm is inserted into the osteotomy firstly to a depth of 1 mm away from the sinus floor with light malleting by the nylon cap mallet then 3 mm osteotome is used to fracture up the sinus floor and finally 3.5 mm osteotome is tapped gently to elevate the sinus floor to the desired depth of the implant in the maxillary sinus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>densah bur</intervention_name>
    <description>osseodensification densah bur</description>
    <arm_group_label>control group :osteotome group</arm_group_label>
    <arm_group_label>intervention arm :densah bur group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the residual bone height at the site of implant placement was 8 mm or less. All&#xD;
             patients were in a good health, non-smokers with no systemic, immunologic or&#xD;
             debilitating diseases that could affect normal bone healing. Their edentulous ridges&#xD;
             were covered with optimal thickness of mucoperiosteum with no signs of inflammation,&#xD;
             ulceration or scar tissue and sufficient inter arch space was adequate for future&#xD;
             prosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers bad oral hygiene systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doaa A Heshmat, lecturer</last_name>
    <role>Study Director</role>
    <affiliation>faculty of dentistry ,Cairo Uni</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of dentistry ,Cairo Uni</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>1211</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Almutairi AS, Walid MA, Alkhodary MA. The effect of osseodensification and different thread designs on the dental implant primary stability. F1000Res. 2018 Dec 5;7:1898. doi: 10.12688/f1000research.17292.1. eCollection 2018.</citation>
    <PMID>31131085</PMID>
  </results_reference>
  <results_reference>
    <citation>Padhye NM, Padhye AM, Bhatavadekar NB. Osseodensification -- A systematic review and qualitative analysis of published literature. J Oral Biol Craniofac Res. 2020 Jan-Mar;10(1):375-380. doi: 10.1016/j.jobcr.2019.10.002. Epub 2019 Nov 2.</citation>
    <PMID>31737477</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Doaa Amr Heshmat</investigator_full_name>
    <investigator_title>lecturer od prosthodontic dep,</investigator_title>
  </responsible_party>
  <keyword>Sinus lifting</keyword>
  <keyword>CBCT</keyword>
  <!-- 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/NCT04481867
org study id: sinus lift densah bur
nct id: NCT04481867
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the clinical complications that might be presented with
      osteotome and densah burs, as well as to assess the new bone generated at 6 months
      post-operatively using CBCT. The study hypothesis was that densah bur would show comparable
      results to osteotome-mediated sinus lifting
Maxillary posterior edentulous area rehabilitation with implants is usually not an easy
      procedure and is considered a challenge to many prosthodontists. This is due to
      pneumatization of the maxillary sinus, poor bone density and volume, and difficult
      accessibility of this area. After tooth loss, the maxillary sinus tends to enlarge into the
      remaining residual ridge because of poor bone density and lack of functional stimulation by
      teeth.1 Rehabilitation with dental implants in the maxillary posterior area depends on the
      quantity and quality of bone available for implant placement. In order to place the implant
      in the best prosthetic position, regenerative surgical techniques are usually essential to
      correct the initial anatomical situation.2 Summer in 1994 introduced a less invasive
      technique than the lateral approach for sinus floor elevation, called the closed sinus
      lifting. Summer classified it in to osteotome sinus floor elevation and bone added osteotome
      sinus floor elevation. Osteotome depends on condensing the bone in implant bed site and
      pushing it laterally and upward, which raises the sinus floor. Although being successful and
      non-invasive, Summer's technique showed several surgical problems as heat generation-induced
      necrosis if not well irrigated, and delayed implant secondary stability, as well as some
      patient-related drawbacks as headache and vertigo.3 Fortunately, in 2014 Salah Huwais
      introduced new burs called densah burs that help preservation of bone health by condensing
      bone rather than removing it. Accordingly, this process was labeled osseodensification. In
      the past few years since the introduction of densah burs, limited number of studies evaluated
      its efficiency as well as patient perception to the procedure. 4 It is well established that
      cone beam computed tomography (CBCT) gives more profound and accurate assessment of pre- and
      post-operative implant sites. However, a meta-analysis was published in 2018 showed that most
      previous studies on lifting procedures used conventional 2D techniques, and very few applied
      CBCT as the diagnostic modality. This heterogeneity highly affected the quality of evidence
      retrieved. 5 This study aimed to validate the clinical complications that might be presented
      with osteotome and densah burs, as well as to assess the new bone generated at 6 months
      post-operatively using CBCT. The study hypothesis was that densah bur would show comparable
      results to osteotome-mediated sinus lifting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized control trail
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: blinded
measure: Clinical patient perception
time frame: 7 days postoperative
description: assessment with Health-Related Quality of Life (HRQOL) questionnaire
measure: Radio-graphic (CBCT) assessment
time frame: preoperative and 6 month postoperative
description: New bone length around the implant ,in millimetre
arm group label: intervention arm :densah bur group
arm group type: Active Comparator
description: at the maxillary molar area for implant placement ,,just after making initial drilling perforation close to the sinus floor, the direction of the drill is reversed and the cutting speed is raised to 1200 rpm, then 2 successive densah burs are used to elevate sinus membrane 2 mm and to prepare implant hole to the selected implant size .for both groups the selected implant size, 4.2 mm width and 10 mm. length
arm group label: control group :osteotome group
arm group type: Other
description: at the maxillary molar area for implant placement .a set of concave osteotomes with different dimensions sequentially used to widen the osteotomy site by surgical mallet. Osteotome 2.5 mm is inserted into the osteotomy firstly to a depth of 1 mm away from the sinus floor with light malleting by the nylon cap mallet then 3 mm osteotome is used to fracture up the sinus floor and finally 3.5 mm osteotome is tapped gently to elevate the sinus floor to the desired depth of the implant in the maxillary sinus.
intervention type: Procedure
intervention name: densah bur
description: osseodensification densah bur
arm group label: control group :osteotome group
arm group label: intervention arm :densah bur group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: No
last name: Doaa A Heshmat, lecturer
role: Study Director
affiliation: faculty of dentistry ,Cairo Uni
facility: 
country: Egypt
citation: Almutairi AS, Walid MA, Alkhodary MA. The effect of osseodensification and different thread designs on the dental implant primary stability. F1000Res. 2018 Dec 5;7:1898. doi: 10.12688/f1000research.17292.1. eCollection 2018.
PMID: 31131085
citation: Padhye NM, Padhye AM, Bhatavadekar NB. Osseodensification -- A systematic review and qualitative analysis of published literature. J Oral Biol Craniofac Res. 2020 Jan-Mar;10(1):375-380. doi: 10.1016/j.jobcr.2019.10.002. Epub 2019 Nov 2.
PMID: 31737477
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Doaa Amr Heshmat
investigator title: lecturer od prosthodontic dep,