<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/NCT04414709</url>
  </required_header>
  <id_info>
    <org_study_id>IORG 0008839</org_study_id>
    <nct_id>NCT04414709</nct_id>
  </id_info>
  <brief_title>Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge</brief_title>
  <official_title>Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge (A Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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 this study was to evaluate clinically and radiographically the splinted short&#xD;
      implants' and single short implants' stability and bone condition before and after loading,&#xD;
      in atrophic posterior mandibular alveolar ridges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study was conducted on 16 Patients with missing posterior molars. Group A: 8&#xD;
      patients had 2 short implants placed in atrophic posterior mandibular alveolar ridge. Group&#xD;
      B: 8 patients had a single short implant placed in atrophic posterior mandibular alveolar&#xD;
      ridge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">January 20, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant Stability</measure>
    <time_frame>Immediately after the operation</time_frame>
    <description>Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means &gt;70 ISQ, between 60-69 is medium stability and &lt; 60 ISQ is considered as low stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implant Stability</measure>
    <time_frame>3 months</time_frame>
    <description>Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means &gt;70 ISQ, between 60-69 is medium stability and &lt; 60 ISQ is considered as low stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implant Stability</measure>
    <time_frame>6 months</time_frame>
    <description>Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means &gt;70 ISQ, between 60-69 is medium stability and &lt; 60 ISQ is considered as low stability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Alveolar Bone Loss</condition>
  <arm_group>
    <arm_group_label>Two short implants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single short implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Double short implant</intervention_name>
    <description>Patients receives 2 short implants to restore missing posterior teeth, loaded with splinted screw retained crowns.</description>
    <arm_group_label>Two short implants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single short implant</intervention_name>
    <description>Patients receives single short implants, loaded with single screw retained crowns.</description>
    <arm_group_label>Single short implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Missing Posterior teeth, indicated for short implant placement.&#xD;
&#xD;
          -  Residual alveolar ridge at 6-8 mm height and at least 7mm width.&#xD;
&#xD;
          -  Healthy band of keratinized attached mucosa.&#xD;
&#xD;
          -  Good Oral hygiene.&#xD;
&#xD;
          -  Medically fit patient, free from relevant diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically compromised patients.&#xD;
&#xD;
          -  Imunnocompromised patients&#xD;
&#xD;
          -  Patients with Para-functional habits.&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Poor Oral hygiene.&#xD;
&#xD;
          -  Patient refuse to undergo the surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Glantz PO, Nilner K. Biomechanical aspects of prosthetic implant-borne reconstructions. Periodontol 2000. 1998 Jun;17:119-24. doi: 10.1111/j.1600-0757.1998.tb00129.x. No abstract available.</citation>
    <PMID>10337319</PMID>
  </reference>
  <reference>
    <citation>Renouard F, Nisand D. Short implants in the severely resorbed maxilla: a 2-year retrospective clinical study. Clin Implant Dent Relat Res. 2005;7 Suppl 1:S104-10. doi: 10.1111/j.1708-8208.2005.tb00082.x.</citation>
    <PMID>16137095</PMID>
  </reference>
  <reference>
    <citation>Tallgren A. The reduction in face height of edentulous and partially edentulous subjects during long-term denture wear. A longitudinal roentgenographic cephalometric study. Acta Odontol Scand. 1966 Sep;24(2):195-239. doi: 10.3109/00016356609026127. No abstract available.</citation>
    <PMID>5225747</PMID>
  </reference>
  <reference>
    <citation>Nevins M, Al Hezaimi K, Schupbach P, Karimbux N, Kim DM. Vertical ridge augmentation using an equine bone and collagen block infused with recombinant human platelet-derived growth factor-BB: a randomized single-masked histologic study in non-human primates. J Periodontol. 2012 Jul;83(7):878-84. doi: 10.1902/jop.2012.110478. Epub 2012 Jan 5.</citation>
    <PMID>22220770</PMID>
  </reference>
  <reference>
    <citation>Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.</citation>
    <PMID>19885448</PMID>
  </reference>
  <reference>
    <citation>das Neves FD, Fones D, Bernardes SR, do Prado CJ, Neto AJ. Short implants--an analysis of longitudinal studies. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):86-93.</citation>
    <PMID>16519186</PMID>
  </reference>
  <reference>
    <citation>Neldam CA, Pinholt EM. State of the art of short dental implants: a systematic review of the literature. Clin Implant Dent Relat Res. 2012 Aug;14(4):622-32. doi: 10.1111/j.1708-8208.2010.00303.x. Epub 2010 Oct 26.</citation>
    <PMID>20977606</PMID>
  </reference>
  <reference>
    <citation>Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26.</citation>
    <PMID>25418606</PMID>
  </reference>
  <reference>
    <citation>Lemos CA, Ferro-Alves ML, Okamoto R, Mendonca MR, Pellizzer EP. Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis. J Dent. 2016 Apr;47:8-17. doi: 10.1016/j.jdent.2016.01.005. Epub 2016 Jan 19.</citation>
    <PMID>26804969</PMID>
  </reference>
  <reference>
    <citation>Misch CE, Steignga J, Barboza E, Misch-Dietsh F, Cianciola LJ, Kazor C. Short dental implants in posterior partial edentulism: a multicenter retrospective 6-year case series study. J Periodontol. 2006 Aug;77(8):1340-7. doi: 10.1902/jop.2006.050402.</citation>
    <PMID>16937587</PMID>
  </reference>
  <reference>
    <citation>Menchero-Cantalejo E, Barona-Dorado C, Cantero-Alvarez M, Fernandez-Caliz F, Martinez-Gonzalez JM. Meta-analysis on the survival of short implants. Med Oral Patol Oral Cir Bucal. 2011 Jul 1;16(4):e546-51. doi: 10.4317/medoral.16.e546.</citation>
    <PMID>21196883</PMID>
  </reference>
  <reference>
    <citation>Lum LB. A biomechanical rationale for the use of short implants. J Oral Implantol. 1991;17(2):126-31.</citation>
    <PMID>1811063</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>fady michel tadros hanna</investigator_full_name>
    <investigator_title>Oral Surgery Master's student</investigator_title>
  </responsible_party>
  <keyword>Short implant</keyword>
  <keyword>Splinted short implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT04414709
org study id: IORG 0008839
nct id: NCT04414709
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate clinically and radiographically the splinted short
      implants' and single short implants' stability and bone condition before and after loading,
      in atrophic posterior mandibular alveolar ridges.
A prospective study was conducted on 16 Patients with missing posterior molars. Group A: 8
      patients had 2 short implants placed in atrophic posterior mandibular alveolar ridge. Group
      B: 8 patients had a single short implant placed in atrophic posterior mandibular alveolar
      ridge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Implant Stability
time frame: Immediately after the operation
description: Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
measure: Implant Stability
time frame: 3 months
description: Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
measure: Implant Stability
time frame: 6 months
description: Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
arm group label: Two short implants
arm group type: Experimental
description: DENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.
arm group label: Single short implant
arm group type: Active Comparator
description: DENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.
intervention type: Other
intervention name: Double short implant
description: Patients receives 2 short implants to restore missing posterior teeth, loaded with splinted screw retained crowns.
arm group label: Two short implants
intervention type: Other
intervention name: Single short implant
description: Patients receives single short implants, loaded with single screw retained crowns.
arm group label: Single short implant
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Glantz PO, Nilner K. Biomechanical aspects of prosthetic implant-borne reconstructions. Periodontol 2000. 1998 Jun;17:119-24. doi: 10.1111/j.1600-0757.1998.tb00129.x. No abstract available.
PMID: 10337319
citation: Renouard F, Nisand D. Short implants in the severely resorbed maxilla: a 2-year retrospective clinical study. Clin Implant Dent Relat Res. 2005;7 Suppl 1:S104-10. doi: 10.1111/j.1708-8208.2005.tb00082.x.
PMID: 16137095
citation: Tallgren A. The reduction in face height of edentulous and partially edentulous subjects during long-term denture wear. A longitudinal roentgenographic cephalometric study. Acta Odontol Scand. 1966 Sep;24(2):195-239. doi: 10.3109/00016356609026127. No abstract available.
PMID: 5225747
citation: Nevins M, Al Hezaimi K, Schupbach P, Karimbux N, Kim DM. Vertical ridge augmentation using an equine bone and collagen block infused with recombinant human platelet-derived growth factor-BB: a randomized single-masked histologic study in non-human primates. J Periodontol. 2012 Jul;83(7):878-84. doi: 10.1902/jop.2012.110478. Epub 2012 Jan 5.
PMID: 22220770
citation: Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
PMID: 19885448
citation: das Neves FD, Fones D, Bernardes SR, do Prado CJ, Neto AJ. Short implants--an analysis of longitudinal studies. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):86-93.
PMID: 16519186
citation: Neldam CA, Pinholt EM. State of the art of short dental implants: a systematic review of the literature. Clin Implant Dent Relat Res. 2012 Aug;14(4):622-32. doi: 10.1111/j.1708-8208.2010.00303.x. Epub 2010 Oct 26.
PMID: 20977606
citation: Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26.
PMID: 25418606
citation: Lemos CA, Ferro-Alves ML, Okamoto R, Mendonca MR, Pellizzer EP. Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis. J Dent. 2016 Apr;47:8-17. doi: 10.1016/j.jdent.2016.01.005. Epub 2016 Jan 19.
PMID: 26804969
citation: Misch CE, Steignga J, Barboza E, Misch-Dietsh F, Cianciola LJ, Kazor C. Short dental implants in posterior partial edentulism: a multicenter retrospective 6-year case series study. J Periodontol. 2006 Aug;77(8):1340-7. doi: 10.1902/jop.2006.050402.
PMID: 16937587
citation: Menchero-Cantalejo E, Barona-Dorado C, Cantero-Alvarez M, Fernandez-Caliz F, Martinez-Gonzalez JM. Meta-analysis on the survival of short implants. Med Oral Patol Oral Cir Bucal. 2011 Jul 1;16(4):e546-51. doi: 10.4317/medoral.16.e546.
PMID: 21196883
citation: Lum LB. A biomechanical rationale for the use of short implants. J Oral Implantol. 1991;17(2):126-31.
PMID: 1811063
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: fady michel tadros hanna
investigator title: Oral Surgery Master's student
mesh term: Alveolar Bone Loss