<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/NCT04408781</url>
  </required_header>
  <id_info>
    <org_study_id>104</org_study_id>
    <nct_id>NCT04408781</nct_id>
  </id_info>
  <brief_title>Management of Narrow Alveolar Ridges Via Densah-bur Versus Piezoelectric</brief_title>
  <official_title>Clinical &amp; Radiographic Evaluation of Split-crest Ridge Technique Versus Osseodensification Technique for Dental Implant Placement Into Narrow Alveolar Ridge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar 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>
      The aim of the present study is to evaluate Clinical &amp; radiographic evaluation of split-crest&#xD;
      ridge technique versus osseodensification technique for dental implant placement into narrow&#xD;
      alveolar Ridge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate ridge width gain in patients with narrow alveolar ridges&#xD;
      followingc osseodensification as compared to ridge splitting with simultaneous implant&#xD;
      placement using CBCT.&#xD;
&#xD;
      Interventions: I. Pre-operative phase: Clinical Examination: 1. Visual examination, palpation&#xD;
      and inspection of the entire oral and Para-oral tissues. 2. Preoperative alginate impressions&#xD;
      for both the maxillary and the mandibular Ridges. 3. Full mouth scaling and root planing,&#xD;
      followed by oral hygiene instructions. 4. The Bucco-Lingual/Palatal alveolar ridge width&#xD;
      measurement at site of interest using a bone caliper. 5. Study casts will be made in order to&#xD;
      properly evaluate the inter-arch space, occlusion type and direction of forces in regard to&#xD;
      the site of the future implant. Radiographic Examination: 1. A panoramic radiograph for&#xD;
      screening purposes: - estimating the residual bone height. - Verify the absence of any&#xD;
      pathology in the bone. 2. Cone beam computed Tomography (CBCT) for Diagnostic purposes: -&#xD;
      Detect the Bucco-lingual/palatal alveolar ridge width and height at the site of interest. -&#xD;
      Detect approximation to any anatomical boundaries (e.g.mental foramen, maxillary sinus&#xD;
      floor.) -Detect bone type. II. Surgical phase: All procedures will be done under strictly&#xD;
      aseptic conditions 1. Patients will be anesthetized at the surgical site by the appropriate&#xD;
      method using Articaine Hydrochloride 4%. 2. At the site a horizontal incision will be&#xD;
      created, extending the entire length of the edentulous area, extending one tooth mesial and&#xD;
      distal. Anterior and/or posterior vertical releasing incision will be made as needed. 3. Full&#xD;
      thickness mucoperiosteal ~ap will be raised with complete exposure of the alveolar bone. 4.&#xD;
      Bone width will be recon}rmed intrasurgically using a bone caliper. Measurements will be&#xD;
      taken at around 1 mm below the crestal margin, to the nearest 0.5mm. Alveolar ridge width&#xD;
      measurements will be repeated at second stage surgery. 5. A.For the intervention: 1. Drilling&#xD;
      f bone will commence using the Pilot Drill to the desired depth (Drill speed 800-1500 rpm&#xD;
      with copious irrigation). 2. Osseodensification drilling will begin with the narrowest Densah&#xD;
      Bur. (Counterclockwise drill speed 800-1500 rpm with copious irrigation). If when running the&#xD;
      bur into the osteotomy a feeling of haptic feedback of pushing up and out of the osteotomy,&#xD;
      repetitively lifting off and reapplying pressure with a pumping motion will be applied until&#xD;
      the desired depth is reached. 3. Densah Burs will be used sequentially in small increments.&#xD;
      As the bur diameter increases, the bone will slowly expand to the final diameter. 4. The&#xD;
      osteotomy final preparation diameter would be an average diameter that measures 0.5-0.8 mm&#xD;
      smaller than the implant average diameter in soft bone, and In hard bone, diameter that&#xD;
      measures 0.2-0.5 mm smaller than the implant average diameter. 5. Implant placement using the&#xD;
      drill motor initially, then Finishing placement of the implant to depth with a&#xD;
      torque-indicating wrench. 6. If &lt; 1mm of buccal bone thickness has resulted after&#xD;
      osseodensification, bone grafting post implant placement and complete implant coverage will&#xD;
      be considered 5.B.For the control: 1. A bone crestal incision will be created, using the&#xD;
      piezo-electric surgical tips. The cut will be done through the cortical bone to reach the&#xD;
      trabecular bone. 2. One/two vertical cuts will be created by piezo-drill as needed&#xD;
      connecting, to the crestal cut. 3. Conventional Drills will be used for osteotomy preparation&#xD;
      by wedging it between the two plates of bone. 4. The implant with the proper length and&#xD;
      diameter will be gradually engaged to separate the buccal and Lingual/palatal bone until full&#xD;
      seating is achieved. 6. Cover screws will be placed on the implants. 7.Closure of the ~ap&#xD;
      will be done by interrupted sutures using 4-0 resorbable suture materials. III.&#xD;
      Post-operative phase: Post-operative instructions and medication: Patient is recommended to:&#xD;
      1. Maintain a soft diet to avoid trauma to the surgical site. 2. Place a cold compress&#xD;
      super}cially on the skin overlying the surgical site immediately. Apply for 30 minutes, then&#xD;
      off for 20-30 minutes. This should be done on a near continuous basis (or as much as&#xD;
      possible) for the }first 48 hours. 3. Maintain Oral hygiene but avoid surgical site for the&#xD;
      }rst 4 days after surgery. 4. Medications (Ferrigno et al. 2005)( Garcez-Filho et al.2015) •&#xD;
      Augmentin* (1g tablets) will be prescribed twice daily for 5 days to avoid possibility of&#xD;
      infection. • Ibuprofen** 600mg four times daily for one week. • Voltarene*** (75 mg injection&#xD;
      I.M.) will be used in case of severe pain, as a rescue. • Hexitol**** 0.12% chlorhexidine&#xD;
      mouth rinse for 2 weeks. 5. Sutures will be removed after 2 weeks 6. Final restoration will&#xD;
      be completed after 6 months - Augmentin 1g. Medical union pharmaceuticals co. Abu Sultan,&#xD;
      Ismailia, Egypt. **BRUFEN 600 (Ibuprofen 600 mg). Kahira Pharm. &amp; Chem. Ind. Co., Under&#xD;
      licence from: Abbott Laboratories. - Voltarene® 75mg/3ml (IM). Diclofenac natrium. NOVARTIS&#xD;
      PHARMA. S.A.E. - Hexitol Chlorhexidine Hcl 125 mg / 100 ml. Arab Drug Company (ADCO).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bone width</measure>
    <time_frame>Baseline and six month post surgically</time_frame>
    <description>Cone beam computed tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Implant stability</measure>
    <time_frame>Baseline and six month post surgically</time_frame>
    <description>osstell</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Knife Edge Alveolar Ridge</condition>
  <arm_group>
    <arm_group_label>Ridge expansion by osseodensifcation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ridge expansion and osteotomy drilling by osseodensifcation in conjunction with simultaneous implant placement in narrow ridges</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ridge expansion by ridge splitting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting</intervention_name>
    <description>Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.</description>
    <arm_group_label>Ridge expansion by osseodensifcation</arm_group_label>
    <arm_group_label>Ridge expansion by ridge splitting</arm_group_label>
    <other_name>Ridge expansion by ridge splitting</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with missing tooth which is needed for replacement.&#xD;
&#xD;
          2. Patients having a Bucco-lingual/palatal width of the edentulous alveolar ridge less&#xD;
             than 6 mm. with a minimum of 3mm. residual bone width.&#xD;
&#xD;
          3. Patients having at least 11 mm residual bone height at the proposed edentulous area.&#xD;
&#xD;
          4. The recipient bed of the implant should be free from any pathological conditions.&#xD;
&#xD;
          5. No history of diagnosed bone disease or medication known to affect bone metabolism.&#xD;
&#xD;
          6. Patients who are cooperative, motivated, and has good oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients incapable to undergoing minor oral surgical procedures.&#xD;
&#xD;
          2. Patients with insuf}cient vertical inter-arch space, upon centric occlusion, to&#xD;
             accommodate the available restorative components.&#xD;
&#xD;
          3. Patients who have any systemic condition that may contraindicate implant therapy.&#xD;
&#xD;
          4. Patients with modifying habits affecting osteointegration for example, smoking and&#xD;
             alcoholism.&#xD;
&#xD;
          5. Patients with parafunctional habits that can overload the implant, such as bruxism and&#xD;
             clenching.&#xD;
&#xD;
          6. Patients with impractical expectations about the esthetic outcome of implant therapy.&#xD;
&#xD;
          7. Patients in the growth stage with mixed dentition.&#xD;
&#xD;
          8. Patients with a history of drug abuse.&#xD;
&#xD;
          9. Patients with a history of psychiatric disorder. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed abd El-Nabi Bilal, MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Faculty of Dentistry -AL-AZHAR University</name>
      <address>
        <city>Cairo</city>
        <zip>11371</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>February 12, 2021</last_update_submitted>
  <last_update_submitted_qc>February 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Ahmed Abd el-Nabi Mohamed Amin Bilal</investigator_full_name>
    <investigator_title>assistant lecturer of periodontology &amp; oral radiology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04408781
org study id: 104
nct id: NCT04408781
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to evaluate Clinical & radiographic evaluation of split-crest
      ridge technique versus osseodensification technique for dental implant placement into narrow
      alveolar Ridge.
The aim of the study is to evaluate ridge width gain in patients with narrow alveolar ridges
      followingc osseodensification as compared to ridge splitting with simultaneous implant
      placement using CBCT.

      Interventions: I. Pre-operative phase: Clinical Examination: 1. Visual examination, palpation
      and inspection of the entire oral and Para-oral tissues. 2. Preoperative alginate impressions
      for both the maxillary and the mandibular Ridges. 3. Full mouth scaling and root planing,
      followed by oral hygiene instructions. 4. The Bucco-Lingual/Palatal alveolar ridge width
      measurement at site of interest using a bone caliper. 5. Study casts will be made in order to
      properly evaluate the inter-arch space, occlusion type and direction of forces in regard to
      the site of the future implant. Radiographic Examination: 1. A panoramic radiograph for
      screening purposes: - estimating the residual bone height. - Verify the absence of any
      pathology in the bone. 2. Cone beam computed Tomography (CBCT) for Diagnostic purposes: -
      Detect the Bucco-lingual/palatal alveolar ridge width and height at the site of interest. -
      Detect approximation to any anatomical boundaries (e.g.mental foramen, maxillary sinus
      floor.) -Detect bone type. II. Surgical phase: All procedures will be done under strictly
      aseptic conditions 1. Patients will be anesthetized at the surgical site by the appropriate
      method using Articaine Hydrochloride 4%. 2. At the site a horizontal incision will be
      created, extending the entire length of the edentulous area, extending one tooth mesial and
      distal. Anterior and/or posterior vertical releasing incision will be made as needed. 3. Full
      thickness mucoperiosteal ~ap will be raised with complete exposure of the alveolar bone. 4.
      Bone width will be recon}rmed intrasurgically using a bone caliper. Measurements will be
      taken at around 1 mm below the crestal margin, to the nearest 0.5mm. Alveolar ridge width
      measurements will be repeated at second stage surgery. 5. A.For the intervention: 1. Drilling
      f bone will commence using the Pilot Drill to the desired depth (Drill speed 800-1500 rpm
      with copious irrigation). 2. Osseodensification drilling will begin with the narrowest Densah
      Bur. (Counterclockwise drill speed 800-1500 rpm with copious irrigation). If when running the
      bur into the osteotomy a feeling of haptic feedback of pushing up and out of the osteotomy,
      repetitively lifting off and reapplying pressure with a pumping motion will be applied until
      the desired depth is reached. 3. Densah Burs will be used sequentially in small increments.
      As the bur diameter increases, the bone will slowly expand to the final diameter. 4. The
      osteotomy final preparation diameter would be an average diameter that measures 0.5-0.8 mm
      smaller than the implant average diameter in soft bone, and In hard bone, diameter that
      measures 0.2-0.5 mm smaller than the implant average diameter. 5. Implant placement using the
      drill motor initially, then Finishing placement of the implant to depth with a
      torque-indicating wrench. 6. If < 1mm of buccal bone thickness has resulted after
      osseodensification, bone grafting post implant placement and complete implant coverage will
      be considered 5.B.For the control: 1. A bone crestal incision will be created, using the
      piezo-electric surgical tips. The cut will be done through the cortical bone to reach the
      trabecular bone. 2. One/two vertical cuts will be created by piezo-drill as needed
      connecting, to the crestal cut. 3. Conventional Drills will be used for osteotomy preparation
      by wedging it between the two plates of bone. 4. The implant with the proper length and
      diameter will be gradually engaged to separate the buccal and Lingual/palatal bone until full
      seating is achieved. 6. Cover screws will be placed on the implants. 7.Closure of the ~ap
      will be done by interrupted sutures using 4-0 resorbable suture materials. III.
      Post-operative phase: Post-operative instructions and medication: Patient is recommended to:
      1. Maintain a soft diet to avoid trauma to the surgical site. 2. Place a cold compress
      super}cially on the skin overlying the surgical site immediately. Apply for 30 minutes, then
      off for 20-30 minutes. This should be done on a near continuous basis (or as much as
      possible) for the }first 48 hours. 3. Maintain Oral hygiene but avoid surgical site for the
      }rst 4 days after surgery. 4. Medications (Ferrigno et al. 2005)( Garcez-Filho et al.2015) •
      Augmentin* (1g tablets) will be prescribed twice daily for 5 days to avoid possibility of
      infection. • Ibuprofen** 600mg four times daily for one week. • Voltarene*** (75 mg injection
      I.M.) will be used in case of severe pain, as a rescue. • Hexitol**** 0.12% chlorhexidine
      mouth rinse for 2 weeks. 5. Sutures will be removed after 2 weeks 6. Final restoration will
      be completed after 6 months - Augmentin 1g. Medical union pharmaceuticals co. Abu Sultan,
      Ismailia, Egypt. **BRUFEN 600 (Ibuprofen 600 mg). Kahira Pharm. & Chem. Ind. Co., Under
      licence from: Abbott Laboratories. - Voltarene® 75mg/3ml (IM). Diclofenac natrium. NOVARTIS
      PHARMA. S.A.E. - Hexitol Chlorhexidine Hcl 125 mg / 100 ml. Arab Drug Company (ADCO).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in bone width
time frame: Baseline and six month post surgically
description: Cone beam computed tomography
measure: Change in Implant stability
time frame: Baseline and six month post surgically
description: osstell
arm group label: Ridge expansion by osseodensifcation
arm group type: Experimental
description: Ridge expansion and osteotomy drilling by osseodensifcation in conjunction with simultaneous implant placement in narrow ridges
arm group label: Ridge expansion by ridge splitting
arm group type: Active Comparator
description: Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.
intervention type: Procedure
intervention name: Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting
description: Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.
arm group label: Ridge expansion by osseodensifcation
arm group label: Ridge expansion by ridge splitting
other name: Ridge expansion by ridge splitting
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed abd El-Nabi Bilal, MSC
role: Principal Investigator
affiliation: Al-Azhar University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed Abd el-Nabi Mohamed Amin Bilal
investigator title: assistant lecturer of periodontology & oral radiology
sharing ipd: No