<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/NCT03010618</url>
  </required_header>
  <id_info>
    <org_study_id>6.2016/45</org_study_id>
    <nct_id>NCT03010618</nct_id>
  </id_info>
  <brief_title>The Effects of Stainless Steel Crowns Applied With Hall Technique on Occlusal Vertical Dimension</brief_title>
  <official_title>Hall Teknik Ile Uygulanan Paslanmaz Celik kronların Okluzal Dikey Boyuta Etkilerinin değerlendirilmesi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>No</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>
      In recent years restoring carious of fractured primary teeth with stainless steel crowns&#xD;
      (SSC) has became more popular than ever. On the other hand the traditional operative approach&#xD;
      of complete removal of caries is steadily losing support due to successful results with&#xD;
      materials of high microleakage resistance.&#xD;
&#xD;
      Treatment time and pain control in asymptomatic teeth has always been a problem in children.&#xD;
      Hall technique is a minimally invasive treatment protocol that doesn't require local&#xD;
      anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.&#xD;
&#xD;
      But this protocol also raised questions in the scientific community about its possible&#xD;
      effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal&#xD;
      contact and increasing vertical dimension.&#xD;
&#xD;
      The aim of our research is to study the effects of Hall technique's premature occlusal&#xD;
      contact on TMJ.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete canine overbite return</measure>
    <time_frame>30 days</time_frame>
    <description>The length of overbite between upper and lower canines will be measured at beginning of the study with marking the overlapping contact point of the upper left canine and length of a straight line to the tip of the lower left canine will be recorded in mm with a standard WHO gingival probe. Full return to this level will be considered as &quot;Complete canine overbite return&quot; and failure to reach this level will in 30 days will require the patient to be scheduled for an extra recall in every 2 weeks until overbite returns to the pretreatment level.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Caries, Dental</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hall technique stainless steel crowns</intervention_name>
    <description>Primary carious tooth will be treated with stainless steel crowns without local anesthesia or caries removal and the increase in the occlusal vertical dimension will be monitored in two subsequent appointments with measuring canine overbite.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No systemical illness&#xD;
&#xD;
          -  Willing to come to control appointments&#xD;
&#xD;
          -  No symptoms of pulpal inflammation&#xD;
&#xD;
          -  To have at least 1, 3 at most dentin caries primary teeth without infection, mobility,&#xD;
             Angle class I profile and molar relation&#xD;
&#xD;
          -  Willing to participate the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of diagnosed systemic illness&#xD;
&#xD;
          -  Anterior/ posterior crossbite&#xD;
&#xD;
          -  Presence of dental pain&#xD;
&#xD;
          -  Root resorption exceeding 2/3's of the treated tooth&#xD;
&#xD;
          -  Gingival inflammation, periodontal disease&#xD;
&#xD;
          -  Signs of parafunctionism, bruxism&#xD;
&#xD;
          -  Facial asymmetry&#xD;
&#xD;
          -  Signs or symptoms of temporomandibular disfunction&#xD;
&#xD;
          -  Not willing to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarp Kaya, DDS,PhD, Pediatric Dentist</last_name>
      <phone>0212 453 17 00</phone>
      <email>dtsarpkaya@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Pınar Kınay Taran, DDS, Pediatric Dentist</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarp Kaya, DDS,PhD, Pediatric Dentist</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meltem Bakkal, DDS,PhD, Pediatric Dentist</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarp Kaya, DDS,PhD, Pediatric Dentist</last_name>
      <phone>00902124531700</phone>
      <email>dtsarpkaya@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Sarp Kaya, DDS,PhD, Pediatric Dentist</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pınar Kınay Taran, DDS, Pediatric Dentist</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meltem Bakkal, DDS,PhD, Pediatric Dentist</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.</citation>
    <PMID>18096042</PMID>
  </reference>
  <reference>
    <citation>Innes NP, Stirrups DR, Evans DJ, Hall N, Leggate M. A novel technique using preformed metal crowns for managing carious primary molars in general practice - a retrospective analysis. Br Dent J. 2006 Apr 22;200(8):451-4; discussion 444. doi: 10.1038/sj.bdj.4813466.</citation>
    <PMID>16703041</PMID>
  </reference>
  <reference>
    <citation>Kindelan SA, Day P, Nichol R, Willmott N, Fayle SA; British Society of Paediatric Dentistry. UK National Clinical Guidelines in Paediatric Dentistry: stainless steel preformed crowns for primary molars. Int J Paediatr Dent. 2008 Nov;18 Suppl 1:20-8. doi: 10.1111/j.1365-263X.2008.00935.x.</citation>
    <PMID>18808544</PMID>
  </reference>
  <results_reference>
    <citation>van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.</citation>
    <PMID>20932395</PMID>
  </results_reference>
  <results_reference>
    <citation>Gallagher S, O'Connell BC, O'Connell AC. Assessment of occlusion after placement of stainless steel crowns in children - a pilot study. J Oral Rehabil. 2014 Oct;41(10):730-6. doi: 10.1111/joor.12196. Epub 2014 Jun 10.</citation>
    <PMID>24913609</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>July 16, 2017</last_update_submitted>
  <last_update_submitted_qc>July 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Mustafa Sarp Kaya</investigator_full_name>
    <investigator_title>Specialist</investigator_title>
  </responsible_party>
  <keyword>hall technique</keyword>
  <keyword>stainless steel crowns</keyword>
  <keyword>temporomandibular joint</keyword>
  <keyword>dental caries</keyword>
  <keyword>occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03010618
org study id: 6.2016/45
nct id: NCT03010618
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In recent years restoring carious of fractured primary teeth with stainless steel crowns
      (SSC) has became more popular than ever. On the other hand the traditional operative approach
      of complete removal of caries is steadily losing support due to successful results with
      materials of high microleakage resistance.

      Treatment time and pain control in asymptomatic teeth has always been a problem in children.
      Hall technique is a minimally invasive treatment protocol that doesn't require local
      anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.

      But this protocol also raised questions in the scientific community about its possible
      effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal
      contact and increasing vertical dimension.

      The aim of our research is to study the effects of Hall technique's premature occlusal
      contact on TMJ.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete canine overbite return
time frame: 30 days
description: The length of overbite between upper and lower canines will be measured at beginning of the study with marking the overlapping contact point of the upper left canine and length of a straight line to the tip of the lower left canine will be recorded in mm with a standard WHO gingival probe. Full return to this level will be considered as "Complete canine overbite return" and failure to reach this level will in 30 days will require the patient to be scheduled for an extra recall in every 2 weeks until overbite returns to the pretreatment level.
arm group label: Study Group
arm group type: Other
intervention type: Other
intervention name: Hall technique stainless steel crowns
description: Primary carious tooth will be treated with stainless steel crowns without local anesthesia or caries removal and the increase in the occlusal vertical dimension will be monitored in two subsequent appointments with measuring canine overbite.
arm group label: Study Group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Turkey
citation: Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.
PMID: 18096042
citation: Innes NP, Stirrups DR, Evans DJ, Hall N, Leggate M. A novel technique using preformed metal crowns for managing carious primary molars in general practice - a retrospective analysis. Br Dent J. 2006 Apr 22;200(8):451-4; discussion 444. doi: 10.1038/sj.bdj.4813466.
PMID: 16703041
citation: Kindelan SA, Day P, Nichol R, Willmott N, Fayle SA; British Society of Paediatric Dentistry. UK National Clinical Guidelines in Paediatric Dentistry: stainless steel preformed crowns for primary molars. Int J Paediatr Dent. 2008 Nov;18 Suppl 1:20-8. doi: 10.1111/j.1365-263X.2008.00935.x.
PMID: 18808544
citation: van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
PMID: 20932395
citation: Gallagher S, O'Connell BC, O'Connell AC. Assessment of occlusion after placement of stainless steel crowns in children - a pilot study. J Oral Rehabil. 2014 Oct;41(10):730-6. doi: 10.1111/joor.12196. Epub 2014 Jun 10.
PMID: 24913609
responsible party type: Principal Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Mustafa Sarp Kaya
investigator title: Specialist
mesh term: Dental Caries
sharing ipd: Undecided