<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/NCT03254069</url>
  </required_header>
  <id_info>
    <org_study_id>Occlusal Bite Force</org_study_id>
    <nct_id>NCT03254069</nct_id>
  </id_info>
  <brief_title>Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children</brief_title>
  <acronym>OBF</acronym>
  <official_title>Changes in Occlusal Bite Force Following Placement of Stainless Steel Crowns on Primary Molars in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jordan University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to determine if restoring primary molars with SSCs would improve&#xD;
      children's OBF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system.&#xD;
      The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw&#xD;
      elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF&#xD;
      has been widely used in dentistry to provide useful data for the evaluation of jaw muscle&#xD;
      function and activity as well as effectiveness of prosthetic therapy.&#xD;
&#xD;
      Many indicators have been believed to assess the functional status of the masticatory system,&#xD;
      such as body size, bite force, number of functional tooth units, and the occlusal contact&#xD;
      area. Dental status formed with dental fillings, dentures, position and the number of teeth&#xD;
      is an important factor in the value of the OBF.&#xD;
&#xD;
      Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found&#xD;
      a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that&#xD;
      the overall tooth decay was not related to the strength of OBF. They suggested that the&#xD;
      severity of tooth decay may be more important than the number of teeth exhibiting decay.&#xD;
&#xD;
      Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but&#xD;
      restorable primary molars. A recent systematic review by Seale and Randall confirmed their&#xD;
      previous work and reviews and appeared to continue to be supportive and in favor of SSCs.&#xD;
&#xD;
      SSCs has been blamed for premature contact related discomfort in the first few weeks after&#xD;
      placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth&#xD;
      will equilibrate over time and return to pretreatment levels in 15 to 30 days.&#xD;
&#xD;
      Several opinions have been reported by parents, children and dentists regarding the improved&#xD;
      mastication efficiency after placement of the SSCs. However, the effects of SSCs placement on&#xD;
      primary molars on OBF have not yet been investigated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Maximum Occlusal Bite Force (MOBF)</measure>
    <time_frame>Six Months post placement</time_frame>
    <description>Occlusal Bite Force will be measured in Newton</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Stainless Steel Crown Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children with SSCs placed and followed longitudinal. Consent was obtained from all parents and verbal assent was obtained. The following data was collected: Demographic Data of the Children, clinical examination, radiographs, treatment planning, details of stainless steel crowns placement, OBF measurements were made before the SSC placement and periodically post placement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A second group consisted of twenty-two children (11 females and 11 males; a mean age of 5.20 ± 0.36 years) were selected to act as a control sample and received no dental treatment. MOBF was recorded in these subjects at T0 and T5 (6 months after).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stainless Steel Crowns</intervention_name>
    <description>SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.</description>
    <arm_group_label>Stainless Steel Crown Arm</arm_group_label>
    <other_name>SSCs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:- Caucasian&#xD;
&#xD;
          -  Healthy child&#xD;
&#xD;
          -  In the primary dentition stage&#xD;
&#xD;
          -  Class I occlusion&#xD;
&#xD;
          -  No facial asymmetry&#xD;
&#xD;
          -  No cross bite&#xD;
&#xD;
          -  Have caries in the eight primary molars indicating placement of SSCs, with no reported&#xD;
             pain on biting and no previous restorations&#xD;
&#xD;
          -  No gingival inflammation&#xD;
&#xD;
          -  No para functional habits&#xD;
&#xD;
        Exclusion Criteria: did not meet the inclusion criteria stated above&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>arwa Owais, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jordan University of Science &amp; Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jordan University of Science and Technology</name>
      <address>
        <city>Irbid</city>
        <zip>22110</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <results_reference>
    <citation>Mountain G, Wood D, Toumba J. Bite force measurement in children with primary dentition. Int J Paediatr Dent. 2011 Mar;21(2):112-8. doi: 10.1111/j.1365-263X.2010.01098.x. Epub 2010 Aug 20.</citation>
    <PMID>20731734</PMID>
  </results_reference>
  <results_reference>
    <citation>Koc D, Dogan A, Bek B. Bite force and influential factors on bite force measurements: a literature review. Eur J Dent. 2010 Apr;4(2):223-32.</citation>
    <PMID>20396457</PMID>
  </results_reference>
  <results_reference>
    <citation>Ohira A, Ono Y, Yano N, Takagi Y. The effect of chewing exercise in preschool children on maximum bite force and masticatory performance. Int J Paediatr Dent. 2012 Mar;22(2):146-53. doi: 10.1111/j.1365-263X.2011.01162.x. Epub 2011 Jul 22.</citation>
    <PMID>21781200</PMID>
  </results_reference>
  <results_reference>
    <citation>Owens S, Buschang PH, Throckmorton GS, Palmer L, English J. Masticatory performance and areas of occlusal contact and near contact in subjects with normal occlusion and malocclusion. Am J Orthod Dentofacial Orthop. 2002 Jun;121(6):602-9. doi: 10.1067/mod.2002.122829.</citation>
    <PMID>12080313</PMID>
  </results_reference>
  <results_reference>
    <citation>Oueis H. Factors affecting masticatory performance of Japanese children. Int J Paediatr Dent. 2009 May;19(3):201-5. doi: 10.1111/j.1365-263X.2008.00965.x. Epub 2009 Jan 16.</citation>
    <PMID>19207738</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsai HH. Maximum bite force and related dental status in children with deciduous dentition. J Clin Pediatr Dent. 2004 Winter;28(2):139-42. doi: 10.17796/jcpd.28.2.j42870t47q4n1715.</citation>
    <PMID>14969373</PMID>
  </results_reference>
  <results_reference>
    <citation>Seale NS. Stainless steel crowns improve success rate of root canal treatment in primary teeth. J Evid Based Dent Pract. 2005 Dec;5(4):205-6. doi: 10.1016/j.jebdp.2005.09.011. No abstract available.</citation>
    <PMID>17138373</PMID>
  </results_reference>
  <results_reference>
    <citation>Atieh M. Stainless steel crown versus modified open-sandwich restorations for primary molars: a 2-year randomized clinical trial. Int J Paediatr Dent. 2008 Sep;18(5):325-32. doi: 10.1111/j.1365-263X.2007.00900.x. Epub 2008 Mar 6.</citation>
    <PMID>18328050</PMID>
  </results_reference>
  <results_reference>
    <citation>Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.</citation>
    <PMID>25905656</PMID>
  </results_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>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>
  </results_reference>
  <results_reference>
    <citation>Owais AI, Shaweesh M, Abu Alhaija ES. Maximum occusal bite force for children in different dentition stages. Eur J Orthod. 2013 Aug;35(4):427-33. doi: 10.1093/ejo/cjs021. Epub 2012 Apr 19.</citation>
    <PMID>22518063</PMID>
  </results_reference>
  <results_reference>
    <citation>Serra MD, Gambareli FR, Gaviao MB. A 1-year intraindividual evaluation of maximum bite force in children wearing a removable partial dental prosthesis. J Dent Child (Chic). 2007 Sep-Dec;74(3):171-6.</citation>
    <PMID>18482509</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>April 8, 2016</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jordan University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Arwa Issa Owais</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>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/NCT03254069
org study id: Occlusal Bite Force
nct id: NCT03254069
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study was to determine if restoring primary molars with SSCs would improve
      children's OBF.
Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system.
      The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw
      elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF
      has been widely used in dentistry to provide useful data for the evaluation of jaw muscle
      function and activity as well as effectiveness of prosthetic therapy.

      Many indicators have been believed to assess the functional status of the masticatory system,
      such as body size, bite force, number of functional tooth units, and the occlusal contact
      area. Dental status formed with dental fillings, dentures, position and the number of teeth
      is an important factor in the value of the OBF.

      Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found
      a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that
      the overall tooth decay was not related to the strength of OBF. They suggested that the
      severity of tooth decay may be more important than the number of teeth exhibiting decay.

      Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but
      restorable primary molars. A recent systematic review by Seale and Randall confirmed their
      previous work and reviews and appeared to continue to be supportive and in favor of SSCs.

      SSCs has been blamed for premature contact related discomfort in the first few weeks after
      placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth
      will equilibrate over time and return to pretreatment levels in 15 to 30 days.

      Several opinions have been reported by parents, children and dentists regarding the improved
      mastication efficiency after placement of the SSCs. However, the effects of SSCs placement on
      primary molars on OBF have not yet been investigated
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Occlusal Bite Force (MOBF)
time frame: Six Months post placement
description: Occlusal Bite Force will be measured in Newton
arm group label: Stainless Steel Crown Arm
arm group type: Experimental
description: Children with SSCs placed and followed longitudinal. Consent was obtained from all parents and verbal assent was obtained. The following data was collected: Demographic Data of the Children, clinical examination, radiographs, treatment planning, details of stainless steel crowns placement, OBF measurements were made before the SSC placement and periodically post placement
arm group label: Control Arm
arm group type: No Intervention
description: A second group consisted of twenty-two children (11 females and 11 males; a mean age of 5.20 ± 0.36 years) were selected to act as a control sample and received no dental treatment. MOBF was recorded in these subjects at T0 and T5 (6 months after).
intervention type: Device
intervention name: Stainless Steel Crowns
description: SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.
arm group label: Stainless Steel Crown Arm
other name: SSCs
criteria: 
gender: All
minimum age: 4 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: arwa Owais, BDS
role: Principal Investigator
affiliation: Jordan University of Science & Technology
facility: 
country: Jordan
citation: Mountain G, Wood D, Toumba J. Bite force measurement in children with primary dentition. Int J Paediatr Dent. 2011 Mar;21(2):112-8. doi: 10.1111/j.1365-263X.2010.01098.x. Epub 2010 Aug 20.
PMID: 20731734
citation: Koc D, Dogan A, Bek B. Bite force and influential factors on bite force measurements: a literature review. Eur J Dent. 2010 Apr;4(2):223-32.
PMID: 20396457
citation: Ohira A, Ono Y, Yano N, Takagi Y. The effect of chewing exercise in preschool children on maximum bite force and masticatory performance. Int J Paediatr Dent. 2012 Mar;22(2):146-53. doi: 10.1111/j.1365-263X.2011.01162.x. Epub 2011 Jul 22.
PMID: 21781200
citation: Owens S, Buschang PH, Throckmorton GS, Palmer L, English J. Masticatory performance and areas of occlusal contact and near contact in subjects with normal occlusion and malocclusion. Am J Orthod Dentofacial Orthop. 2002 Jun;121(6):602-9. doi: 10.1067/mod.2002.122829.
PMID: 12080313
citation: Oueis H. Factors affecting masticatory performance of Japanese children. Int J Paediatr Dent. 2009 May;19(3):201-5. doi: 10.1111/j.1365-263X.2008.00965.x. Epub 2009 Jan 16.
PMID: 19207738
citation: Tsai HH. Maximum bite force and related dental status in children with deciduous dentition. J Clin Pediatr Dent. 2004 Winter;28(2):139-42. doi: 10.17796/jcpd.28.2.j42870t47q4n1715.
PMID: 14969373
citation: Seale NS. Stainless steel crowns improve success rate of root canal treatment in primary teeth. J Evid Based Dent Pract. 2005 Dec;5(4):205-6. doi: 10.1016/j.jebdp.2005.09.011. No abstract available.
PMID: 17138373
citation: Atieh M. Stainless steel crown versus modified open-sandwich restorations for primary molars: a 2-year randomized clinical trial. Int J Paediatr Dent. 2008 Sep;18(5):325-32. doi: 10.1111/j.1365-263X.2007.00900.x. Epub 2008 Mar 6.
PMID: 18328050
citation: Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.
PMID: 25905656
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: 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: Owais AI, Shaweesh M, Abu Alhaija ES. Maximum occusal bite force for children in different dentition stages. Eur J Orthod. 2013 Aug;35(4):427-33. doi: 10.1093/ejo/cjs021. Epub 2012 Apr 19.
PMID: 22518063
citation: Serra MD, Gambareli FR, Gaviao MB. A 1-year intraindividual evaluation of maximum bite force in children wearing a removable partial dental prosthesis. J Dent Child (Chic). 2007 Sep-Dec;74(3):171-6.
PMID: 18482509
responsible party type: Principal Investigator
investigator affiliation: Jordan University of Science and Technology
investigator full name: Arwa Issa Owais
investigator title: Principal Investigator
mesh term: Dental Caries
sharing ipd: Undecided