<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/NCT04437797</url>
  </required_header>
  <id_info>
    <org_study_id>21/4/2020</org_study_id>
    <nct_id>NCT04437797</nct_id>
  </id_info>
  <brief_title>Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement</brief_title>
  <official_title>Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial</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>
      Many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics&#xD;
      and functional issues. This may be due to more than cause as fights, contact sports,&#xD;
      accidents and falls.&#xD;
&#xD;
      However; implant placement might not be the treatment of choice in some situations such as:&#xD;
      medically compromised patients with absolute contraindications for implant placement or&#xD;
      requiring extensive augmentation procedures, growing patients, patients with financial&#xD;
      limitations, in addition to patients living in rural areas with no access for CBCT machines.&#xD;
&#xD;
      Moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a&#xD;
      specific treatment modality, especially in patients having financial limitations.&#xD;
&#xD;
      Regarding the aforementioned conditions, surgical extrusion might be considered a&#xD;
      cost-effective 'often overlooked' alternative compared to immediate single-tooth implant&#xD;
      placement. Regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion&#xD;
      may be a good alternative yielding better soft tissue results as we preserve the natural&#xD;
      tooth with the whole periodontium.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Soft tissue outcome</measure>
    <time_frame>12 months</time_frame>
    <description>Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>12 months</time_frame>
    <description>Tooth and Implant survival (binary)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Broken Teeth</condition>
  <arm_group>
    <arm_group_label>Surgical Extrusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Implant Placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Extrusion</intervention_name>
    <description>The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.</description>
    <arm_group_label>Surgical Extrusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate Implant Placement</intervention_name>
    <description>The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.</description>
    <arm_group_label>Immediate Implant Placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients at 20-40 years old and have no history of periodontal disease. (periodontally&#xD;
             healthy patients)&#xD;
&#xD;
          2. Single rooted teeth; should be single with adjacent intact or restored neighboring&#xD;
             teeth. More than one tooth may be included in the same arch.&#xD;
&#xD;
          3. More than 1:1 crown root ratio, so that the crown to root ratio is 1:1 after extrusion&#xD;
             and restoration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Badly broken-down teeth with active signs of infection.&#xD;
&#xD;
          2. Teeth with vertical root fracture.&#xD;
&#xD;
          3. Teeth with severely tapered root.&#xD;
&#xD;
          4. Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients&#xD;
             with an HbA1c level greater than 8 will be excluded.&#xD;
&#xD;
          5. Potentially uncooperative patients who are not willing to go through the proposed&#xD;
             interventions.&#xD;
&#xD;
          6. Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day). 9&#xD;
&#xD;
          7. History of radiation therapy and/or chemotherapy to the head and neck, or bone&#xD;
             augmentation to implant site.&#xD;
&#xD;
          8. Labial cortical bone fenestration diagnosed from CBCT.&#xD;
&#xD;
          9. Patients with systemic disease that may affect normal healing.&#xD;
&#xD;
         10. Psychiatric problems, emotional instability, and unrealistic esthetic demands.&#xD;
&#xD;
         11. Bruxism.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail T Mansour, B.D.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ismail T Mansour, B.D.S.</last_name>
    <phone>00201003361428</phone>
    <email>ismail.mansour@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Moustafa O Shehata, B.D.S.</last_name>
    <phone>00201225897482</phone>
    <email>moustafa.hassan@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>Bastone EB, Freer TJ, McNamara JR. Epidemiology of dental trauma: a review of the literature. Aust Dent J. 2000 Mar;45(1):2-9. doi: 10.1111/j.1834-7819.2000.tb00234.x.</citation>
    <PMID>10846265</PMID>
  </reference>
  <reference>
    <citation>Gomez-de Diego R, Mang-de la Rosa Mdel R, Romero-Perez MJ, Cutando-Soriano A, Lopez-Valverde-Centeno A. Indications and contraindications of dental implants in medically compromised patients: update. Med Oral Patol Oral Cir Bucal. 2014 Sep 1;19(5):e483-9. doi: 10.4317/medoral.19565.</citation>
    <PMID>24608222</PMID>
  </reference>
  <reference>
    <citation>Clokie CM, Yau DM, Chano L. Autogenous tooth transplantation: an alternative to dental implant placement? J Can Dent Assoc. 2001 Feb;67(2):92-6.</citation>
    <PMID>11253297</PMID>
  </reference>
  <reference>
    <citation>Mamoun JS. On the ferrule effect and the biomechanical stability of teeth restored with cores, posts, and crowns. Eur J Dent. 2014 Apr;8(2):281-286. doi: 10.4103/1305-7456.130639.</citation>
    <PMID>24966784</PMID>
  </reference>
  <reference>
    <citation>Walsh JS, Kafrawy A, Roche JR. The effect of apical modification on the vitality of replanted permanent monkey teeth. ASDC J Dent Child. 1978 Mar-Apr;45(2):146-50. No abstract available.</citation>
    <PMID>96161</PMID>
  </reference>
  <reference>
    <citation>Nugala B, Kumar BS, Sahitya S, Krishna PM. Biologic width and its importance in periodontal and restorative dentistry. J Conserv Dent. 2012 Jan;15(1):12-7. doi: 10.4103/0972-0707.92599.</citation>
    <PMID>22368328</PMID>
  </reference>
  <reference>
    <citation>Bach N, Baylard JF, Voyer R. Orthodontic extrusion: periodontal considerations and applications. J Can Dent Assoc. 2004 Dec;70(11):775-80.</citation>
    <PMID>15588553</PMID>
  </reference>
  <reference>
    <citation>Singh M, Kumar L, Anwar M, Chand P. Immediate dental implant placement with immediate loading following extraction of natural teeth. Natl J Maxillofac Surg. 2015 Jul-Dec;6(2):252-5. doi: 10.4103/0975-5950.183864.</citation>
    <PMID>27390509</PMID>
  </reference>
  <reference>
    <citation>Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.</citation>
    <PMID>19228100</PMID>
  </reference>
  <reference>
    <citation>Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.</citation>
    <PMID>22157097</PMID>
  </reference>
  <reference>
    <citation>Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.</citation>
    <PMID>18332753</PMID>
  </reference>
  <reference>
    <citation>Annibali S, Bignozzi I, La Monaca G, Cristalli MP. Usefulness of the aesthetic result as a success criterion for implant therapy: a review. Clin Implant Dent Relat Res. 2012 Mar;14(1):3-40. doi: 10.1111/j.1708-8208.2009.00234.x. Epub 2009 Aug 6.</citation>
    <PMID>19673953</PMID>
  </reference>
  <reference>
    <citation>Sheng L, Silvestrin T, Zhan J, Wu L, Zhao Q, Cao Z, Lou Z, Ma Q. Replacement of severely traumatized teeth with immediate implants and immediate loading: literature review and case reports. Dent Traumatol. 2015 Dec;31(6):493-503. doi: 10.1111/edt.12201. Epub 2015 Jul 14.</citation>
    <PMID>26176171</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ismail Tarek Mansour</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04437797
org study id: 21/4/2020
nct id: NCT04437797
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics
      and functional issues. This may be due to more than cause as fights, contact sports,
      accidents and falls.

      However; implant placement might not be the treatment of choice in some situations such as:
      medically compromised patients with absolute contraindications for implant placement or
      requiring extensive augmentation procedures, growing patients, patients with financial
      limitations, in addition to patients living in rural areas with no access for CBCT machines.

      Moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a
      specific treatment modality, especially in patients having financial limitations.

      Regarding the aforementioned conditions, surgical extrusion might be considered a
      cost-effective 'often overlooked' alternative compared to immediate single-tooth implant
      placement. Regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion
      may be a good alternative yielding better soft tissue results as we preserve the natural
      tooth with the whole periodontium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Soft tissue outcome
time frame: 12 months
description: Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value
measure: Survival
time frame: 12 months
description: Tooth and Implant survival (binary)
arm group label: Surgical Extrusion
arm group type: Experimental
description: The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.
arm group label: Immediate Implant Placement
arm group type: Active Comparator
description: The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.
intervention type: Procedure
intervention name: Surgical Extrusion
description: The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.
arm group label: Surgical Extrusion
intervention type: Procedure
intervention name: Immediate Implant Placement
description: The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.
arm group label: Immediate Implant Placement
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ismail T Mansour, B.D.S.
role: Principal Investigator
affiliation: Cairo University
last name: Ismail T Mansour, B.D.S.
phone: 00201003361428
email: ismail.mansour@dentistry.cu.edu.eg
last name: Moustafa O Shehata, B.D.S.
phone: 00201225897482
email: moustafa.hassan@dentistry.cu.edu.eg
citation: Bastone EB, Freer TJ, McNamara JR. Epidemiology of dental trauma: a review of the literature. Aust Dent J. 2000 Mar;45(1):2-9. doi: 10.1111/j.1834-7819.2000.tb00234.x.
PMID: 10846265
citation: Gomez-de Diego R, Mang-de la Rosa Mdel R, Romero-Perez MJ, Cutando-Soriano A, Lopez-Valverde-Centeno A. Indications and contraindications of dental implants in medically compromised patients: update. Med Oral Patol Oral Cir Bucal. 2014 Sep 1;19(5):e483-9. doi: 10.4317/medoral.19565.
PMID: 24608222
citation: Clokie CM, Yau DM, Chano L. Autogenous tooth transplantation: an alternative to dental implant placement? J Can Dent Assoc. 2001 Feb;67(2):92-6.
PMID: 11253297
citation: Mamoun JS. On the ferrule effect and the biomechanical stability of teeth restored with cores, posts, and crowns. Eur J Dent. 2014 Apr;8(2):281-286. doi: 10.4103/1305-7456.130639.
PMID: 24966784
citation: Walsh JS, Kafrawy A, Roche JR. The effect of apical modification on the vitality of replanted permanent monkey teeth. ASDC J Dent Child. 1978 Mar-Apr;45(2):146-50. No abstract available.
PMID: 96161
citation: Nugala B, Kumar BS, Sahitya S, Krishna PM. Biologic width and its importance in periodontal and restorative dentistry. J Conserv Dent. 2012 Jan;15(1):12-7. doi: 10.4103/0972-0707.92599.
PMID: 22368328
citation: Bach N, Baylard JF, Voyer R. Orthodontic extrusion: periodontal considerations and applications. J Can Dent Assoc. 2004 Dec;70(11):775-80.
PMID: 15588553
citation: Singh M, Kumar L, Anwar M, Chand P. Immediate dental implant placement with immediate loading following extraction of natural teeth. Natl J Maxillofac Surg. 2015 Jul-Dec;6(2):252-5. doi: 10.4103/0975-5950.183864.
PMID: 27390509
citation: Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.
PMID: 19228100
citation: Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.
PMID: 22157097
citation: Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.
PMID: 18332753
citation: Annibali S, Bignozzi I, La Monaca G, Cristalli MP. Usefulness of the aesthetic result as a success criterion for implant therapy: a review. Clin Implant Dent Relat Res. 2012 Mar;14(1):3-40. doi: 10.1111/j.1708-8208.2009.00234.x. Epub 2009 Aug 6.
PMID: 19673953
citation: Sheng L, Silvestrin T, Zhan J, Wu L, Zhao Q, Cao Z, Lou Z, Ma Q. Replacement of severely traumatized teeth with immediate implants and immediate loading: literature review and case reports. Dent Traumatol. 2015 Dec;31(6):493-503. doi: 10.1111/edt.12201. Epub 2015 Jul 14.
PMID: 26176171
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ismail Tarek Mansour
investigator title: Principal Investigator
mesh term: Tooth Fractures
sharing ipd: Yes