xml: <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/NCT06012409</url>
    </required_header>
    <id_info>
      <org_study_id>DHF-21008</org_study_id>
      <nct_id>NCT06012409</nct_id>
    </id_info>
    <brief_title>Evaluation of the Occlusal Effects of the Hall Technique and Investigation of Children's Satisfaction</brief_title>
    <official_title>Evaluation of the Occlusal Effects of the Hall Technique and Investigation of Children's Satisfaction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aydin Adnan Menderes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cardiff University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Aydin Adnan Menderes 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>
        Background: The Hall Technique (HT) is a non-invasive, easily applicable minimally invasive&#xD;
        dentistry approach for managing dental caries in children. It involves placing a preformed&#xD;
        metal crown over a tooth with decay, to seal it in and stop the decay from progressing.&#xD;
        However, it alters the occlusion as no tooth substance is removed to make space for the&#xD;
        crown.&#xD;
  &#xD;
        Objective: This study, aims to evaluate the effects of Hall Technique on occlusion in&#xD;
        children, to assess whether there are any adverse effects on the temporomandibular joint and&#xD;
        masseter muscles, related to changes on occlusion and to evaluate the children's perceptions&#xD;
        of the crowns.&#xD;
  &#xD;
        Materials and Methods: A total of 37 children aged 5-9 years, who have not been treated with&#xD;
        the Hall Technique previously and who have dentinal caries that did not reach the pulp&#xD;
        (affecting the occlusal or the occluso-proximal surfaces) in their primary molars, will be&#xD;
        invited to participate in the study. At the first visit, clinical examination will be carried&#xD;
        out and intraoral impressions will be taken for pre-treatment evaluation. The occlusal&#xD;
        vertical dimension of the teeth will be measured clinically with callipers. Temporomandibular&#xD;
        joint and masseter muscles will be examined clinically. Then, the Hall Technique crown will&#xD;
        be placed to treat the carious tooth, the impressions taken again, and measurements repeated.&#xD;
        At one and three months following treatment with the crown, the participant will have the&#xD;
        measurements repeated. The child and parent will complete a questionnaire after 3 months on&#xD;
        their perception of the crown.&#xD;
  &#xD;
        In the data analysis, frequency, percentage, mean and standard deviation analyses will be&#xD;
        used for demographic data and description of the clinical data. In numerical data analysis,&#xD;
        t-test or Mann-Whitney U test will be used according to the data distribution. Geomagic&#xD;
        software will be used to analyse sequential study models of the teeth to measure relative&#xD;
        changes in the tooth positions over time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dental caries is one of the most common chronic diseases during childhood. Due to the high&#xD;
        incidence of dental caries in the primary dentition and inadequate treatments, early&#xD;
        childhood caries is an important public health problem for children. The main challenge in&#xD;
        paediatric dentistry, both for the clinician and the family, is to cooperate with the child&#xD;
        to provide the necessary treatment successfully. Although many factors affect dental anxiety,&#xD;
        research shows that the type of dental treatment can influence the child's behaviour.&#xD;
        Minimally invasive dental approaches have been found to offer a more comfortable treatment&#xD;
        process. The Hall Technique is a type of minimally invasive dental treatment. It has been&#xD;
        used for more than 20 years to treat dental caries in children. In this technique, the&#xD;
        carious lesion is sealed under a PMC to stop the progression of caries and prevent pain&#xD;
        and/or infection. A crown is pressed over the tooth without local anaesthesia, tooth&#xD;
        preparation/reduction, or carious tissue removal. This makes the technique less invasive and&#xD;
        it can be more acceptable to children than a traditional filling involving injections and&#xD;
        drilling.&#xD;
  &#xD;
        One of the drawbacks of Hall Technique is that it increases the occlusal vertical dimension&#xD;
        (OVD) because the PMC is placed on the tooth without any preparation. It is possible that an&#xD;
        increase in the occlusal vertical dimension could cause hyperactivity of the masticatory&#xD;
        muscles, an increase in occlusal forces, bruxism, and temporomandibular joint disorders. The&#xD;
        Hall Technique has reportedly temporarily increased the vertical dimension. According to&#xD;
        clinical research, it takes approximately a month for the vertical dimension to return its&#xD;
        pre-treatment state.&#xD;
  &#xD;
        To the best of our knowledge, none of the studies have accurately determined how the child's&#xD;
        occlusion returns to its pre-treatment state after the placement of a Hall Technique&#xD;
        preformed metal crown. The aim of this study is to evaluate the effects of Hall Technique on&#xD;
        occlusion, temporomandibular joint, and masseter muscle in children and the child's&#xD;
        perceptions of the crown.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 18, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Digital Occlusal Analysis</measure>
      <time_frame>Baseline</time_frame>
      <description>3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Digital Occlusal Analysis</measure>
      <time_frame>Immediately After Treatment</time_frame>
      <description>3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Digital Occlusal Analysis</measure>
      <time_frame>1 Month</time_frame>
      <description>3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Digital Occlusal Analysis</measure>
      <time_frame>3 Month</time_frame>
      <description>3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occlusal Vertical Dimension (OVD) Measurements</measure>
      <time_frame>Baseline</time_frame>
      <description>In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occlusal Vertical Dimension (OVD) Measurements</measure>
      <time_frame>Immediately After Treatment</time_frame>
      <description>In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored.This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occlusal Vertical Dimension (OVD) Measurements</measure>
      <time_frame>1 month</time_frame>
      <description>In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occlusal Vertical Dimension (OVD) Measurements</measure>
      <time_frame>3 month</time_frame>
      <description>In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative effects on the TMJ</measure>
      <time_frame>Baseline</time_frame>
      <description>Clinical examination of the TMJ will be done according to AAPD Guidelines. The following questionnaire will be administered to children and parents to detect any negative effects. Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?&#xD;
  a) Yes b) No Is there pain when chewing, talking?&#xD;
  a) Yes b) No Is there pain when opening your mouth wide or yawning?&#xD;
  a) Yes b) No Does biting feel uncomfortable or different from normal?&#xD;
  a) Yes b) No Have you ever had locking or dislocation of the jaw?&#xD;
  a) Yes b) No Is there a history of jaw, head or neck injury?&#xD;
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?&#xD;
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative effects on the TMJ</measure>
      <time_frame>Immediately after treatment</time_frame>
      <description>Clinical examination of the TMJ will be done according to AAPD Guidelines.The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?&#xD;
  a) Yes b) No Is there pain when chewing, talking?&#xD;
  a) Yes b) No Is there pain when opening your mouth wide or yawning?&#xD;
  a) Yes b) No Does biting feel uncomfortable or different from normal?&#xD;
  a) Yes b) No Have you ever had locking or dislocation of the jaw?&#xD;
  a) Yes b) No Is there a history of jaw, head or neck injury?&#xD;
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?&#xD;
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative effects on the TMJ</measure>
      <time_frame>1 month</time_frame>
      <description>Clinical examination of the TMJ will be done according to AAPD Guidelines The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?&#xD;
  a) Yes b) No Is there pain when chewing, talking?&#xD;
  a) Yes b) No Is there pain when opening your mouth wide or yawning?&#xD;
  a) Yes b) No Does biting feel uncomfortable or different from normal?&#xD;
  a) Yes b) No Have you ever had locking or dislocation of the jaw?&#xD;
  a) Yes b) No Is there a history of jaw, head or neck injury?&#xD;
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?&#xD;
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative effects on the TMJ</measure>
      <time_frame>3 month</time_frame>
      <description>Clinical examination of the TMJ will be done according to AAPD Guidelines The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?&#xD;
  a) Yes b) No Is there pain when chewing, talking?&#xD;
  a) Yes b) No Is there pain when opening your mouth wide or yawning?&#xD;
  a) Yes b) No Does biting feel uncomfortable or different from normal?&#xD;
  a) Yes b) No Have you ever had locking or dislocation of the jaw?&#xD;
  a) Yes b) No Is there a history of jaw, head or neck injury?&#xD;
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?&#xD;
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative clinical effects of placing an HTPMC on the masseter muscles.</measure>
      <time_frame>Baseline</time_frame>
      <description>Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=&lt;25 mm 6. Deflection during movement: 0=&lt;2mm,1=2-5mm, 2=&gt;5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative clinical effects of placing an HTPMC on the masseter muscles.</measure>
      <time_frame>Immediately after treatment</time_frame>
      <description>Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects. 1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=&lt;25 mm 6. Deflection during movement: 0=&lt;2mm,1=2-5mm, 2=&gt;5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative clinical effects of placing an HTPMC on the masseter muscles.</measure>
      <time_frame>1 month</time_frame>
      <description>Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=&lt;25 mm 6. Deflection during movement: 0=&lt;2mm,1=2-5mm, 2=&gt;5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative clinical effects of placing an HTPMC on the masseter muscles.</measure>
      <time_frame>3 month</time_frame>
      <description>Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=&lt;25 mm 6. Deflection during movement: 0=&lt;2mm,1=2-5mm, 2=&gt;5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detect any negative clinical effects of placing an HTPMC on the masseter muscles.</measure>
      <time_frame>3 month</time_frame>
      <description>Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=&lt;25 mm 6. Deflection during movement: 0=&lt;2mm,1=2-5mm, 2=&gt;5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the child's satisfaction with their HTPMC.</measure>
      <time_frame>3 Month</time_frame>
      <description>A questionnaire will be carried out through an interview with children to determine what their perception of HTPMC and the procedure is.&#xD;
  I am happy with my fixed tooth&#xD;
  I show my fixed tooth to my friends&#xD;
  I feel happy if people ask to see my fixed tooth&#xD;
  I can eat well with my fixed tooth&#xD;
  My fixed tooth never hurts me&#xD;
  The scale is 0 (strongly agree) 1 (agree) 2 (no opinion) 3 (disagree) 4 (strongly disagree) A higher score indicates a worse outcome.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">37</enrollment>
    <condition>Dental Caries in Children</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hall Technique Prefabricated Metal Crown</intervention_name>
      <description>The Hall Technique is a type of minimally invasive dental treatment. Hall Technique involves sealing the carious lesion under a Prefabricated Metal Crown to stop its progression preventing pain and/or infection.This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Potential participants will be selected and recruited from children attending for routine&#xD;
          dental care at Aydin Adnan Menderes University Paediatric Dentistry Clinic.&#xD;
  &#xD;
          Children and their parents will be invited to participate and will be included in the study&#xD;
          after they have the study discussed with them and they agree to participate, giving&#xD;
          informed consent. Children should meet the inclusion criteria, and/or be none of the&#xD;
          exclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Children are eligible for inclusion if:&#xD;
  &#xD;
            -  they are 5 to 9 years old;&#xD;
  &#xD;
            -  they fit the clinical criteria to receive a HTPMC to manage primary molars carious&#xD;
               lesions;&#xD;
  &#xD;
            -  they have antagonist primary molar&#xD;
  &#xD;
            -  they have not had a HTPMC fitted before;&#xD;
  &#xD;
            -  their parents can understand what is involved in the study and have signed and given&#xD;
               assent to participate;&#xD;
  &#xD;
            -  they can cooperate with dental care including having a dental impression taken; and&#xD;
  &#xD;
            -  their parents are willing and able to bring them to the follow-up appointments 4, and&#xD;
               12 weeks after the treatment.&#xD;
  &#xD;
          Children will be excluded from the study if:&#xD;
  &#xD;
            -  They do not have a parental agreement to participate; or&#xD;
  &#xD;
            -  They have self-reported occlusal parafunctional habits (e.g. bruxism, constantly open&#xD;
               mouths).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>9 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicola INNES, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Cardiff University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bahar Melis AKYILDIZ, DDS</last_name>
      <phone>+905387970703</phone>
      <email>baharmeliss@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Melis AKYILDIZ</name>
        <address>
          <city>Efeler</city>
          <state>Aydın</state>
          <zip>09100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Melis AKYILDIZ, DDS</last_name>
        <phone>5387970703</phone>
        <email>baharmeliss@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Nicola INNES, PhD</last_name>
        <phone>+44 29225 10657</phone>
        <email>InnesN@cardiff.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Bahar Melis AKYILDIZ, DDS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Isil SONMEZ, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nicola INNES, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jennifer GALLOWAY, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Daniela RAGGIO, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Uribe SE, Innes N, Maldupa I. The global prevalence of early childhood caries: A systematic review with meta-analysis using the WHO diagnostic criteria. Int J Paediatr Dent. 2021 Nov;31(6):817-830. doi: 10.1111/ipd.12783. Epub 2021 Apr 30.</citation>
      <PMID>33735529</PMID>
    </reference>
    <reference>
      <citation>Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.</citation>
      <PMID>17935593</PMID>
    </reference>
    <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>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>
    </reference>
    <reference>
      <citation>Abu Serdaneh S, AlHalabi M, Kowash M, Macefield V, Khamis AH, Salami A, Hussein I. Hall technique crowns and children's masseter muscle activity: A surface electromyography pilot study. Int J Paediatr Dent. 2020 May;30(3):303-313. doi: 10.1111/ipd.12611. Epub 2020 Jan 24.</citation>
      <PMID>31894621</PMID>
    </reference>
    <reference>
      <citation>Shih YC, Yang R, Zou J. Assessment of occlusion and temporomandibular joint after placing preformed metal crowns on all primary molars in children. Int J Paediatr Dent. 2022 Nov;32(6):915-924. doi: 10.1111/ipd.12970. Epub 2022 May 18.</citation>
      <PMID>35484864</PMID>
    </reference>
    <reference>
      <citation>Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.</citation>
      <PMID>31158253</PMID>
    </reference>
    <reference>
      <citation>Hesse D, de Araujo MP, Olegario IC, Innes N, Raggio DP, Bonifacio CC. Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:169. doi: 10.1186/s13063-016-1270-z.</citation>
      <PMID>27029801</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
      <investigator_full_name>Melis AKYILDIZ</investigator_full_name>
      <investigator_title>Principle investigator</investigator_title>
    </responsible_party>
    <keyword>Dental Caries</keyword>
    <keyword>Children</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012409
  org study id: DHF-21008
  nct id: NCT06012409
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: The Hall Technique (HT) is a non-invasive, easily applicable minimally invasive
        dentistry approach for managing dental caries in children. It involves placing a preformed
        metal crown over a tooth with decay, to seal it in and stop the decay from progressing.
        However, it alters the occlusion as no tooth substance is removed to make space for the
        crown.
  
        Objective: This study, aims to evaluate the effects of Hall Technique on occlusion in
        children, to assess whether there are any adverse effects on the temporomandibular joint and
        masseter muscles, related to changes on occlusion and to evaluate the children's perceptions
        of the crowns.
  
        Materials and Methods: A total of 37 children aged 5-9 years, who have not been treated with
        the Hall Technique previously and who have dentinal caries that did not reach the pulp
        (affecting the occlusal or the occluso-proximal surfaces) in their primary molars, will be
        invited to participate in the study. At the first visit, clinical examination will be carried
        out and intraoral impressions will be taken for pre-treatment evaluation. The occlusal
        vertical dimension of the teeth will be measured clinically with callipers. Temporomandibular
        joint and masseter muscles will be examined clinically. Then, the Hall Technique crown will
        be placed to treat the carious tooth, the impressions taken again, and measurements repeated.
        At one and three months following treatment with the crown, the participant will have the
        measurements repeated. The child and parent will complete a questionnaire after 3 months on
        their perception of the crown.
  
        In the data analysis, frequency, percentage, mean and standard deviation analyses will be
        used for demographic data and description of the clinical data. In numerical data analysis,
        t-test or Mann-Whitney U test will be used according to the data distribution. Geomagic
        software will be used to analyse sequential study models of the teeth to measure relative
        changes in the tooth positions over time.
  Dental caries is one of the most common chronic diseases during childhood. Due to the high
        incidence of dental caries in the primary dentition and inadequate treatments, early
        childhood caries is an important public health problem for children. The main challenge in
        paediatric dentistry, both for the clinician and the family, is to cooperate with the child
        to provide the necessary treatment successfully. Although many factors affect dental anxiety,
        research shows that the type of dental treatment can influence the child's behaviour.
        Minimally invasive dental approaches have been found to offer a more comfortable treatment
        process. The Hall Technique is a type of minimally invasive dental treatment. It has been
        used for more than 20 years to treat dental caries in children. In this technique, the
        carious lesion is sealed under a PMC to stop the progression of caries and prevent pain
        and/or infection. A crown is pressed over the tooth without local anaesthesia, tooth
        preparation/reduction, or carious tissue removal. This makes the technique less invasive and
        it can be more acceptable to children than a traditional filling involving injections and
        drilling.
  
        One of the drawbacks of Hall Technique is that it increases the occlusal vertical dimension
        (OVD) because the PMC is placed on the tooth without any preparation. It is possible that an
        increase in the occlusal vertical dimension could cause hyperactivity of the masticatory
        muscles, an increase in occlusal forces, bruxism, and temporomandibular joint disorders. The
        Hall Technique has reportedly temporarily increased the vertical dimension. According to
        clinical research, it takes approximately a month for the vertical dimension to return its
        pre-treatment state.
  
        To the best of our knowledge, none of the studies have accurately determined how the child's
        occlusion returns to its pre-treatment state after the placement of a Hall Technique
        preformed metal crown. The aim of this study is to evaluate the effects of Hall Technique on
        occlusion, temporomandibular joint, and masseter muscle in children and the child's
        perceptions of the crown.
  observational model: Cohort
  time perspective: Prospective
  measure: Digital Occlusal Analysis
  time frame: Baseline
  description: 3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
  measure: Digital Occlusal Analysis
  time frame: Immediately After Treatment
  description: 3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
  measure: Digital Occlusal Analysis
  time frame: 1 Month
  description: 3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
  measure: Digital Occlusal Analysis
  time frame: 3 Month
  description: 3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
  measure: Occlusal Vertical Dimension (OVD) Measurements
  time frame: Baseline
  description: In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
  measure: Occlusal Vertical Dimension (OVD) Measurements
  time frame: Immediately After Treatment
  description: In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored.This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
  measure: Occlusal Vertical Dimension (OVD) Measurements
  time frame: 1 month
  description: In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
  measure: Occlusal Vertical Dimension (OVD) Measurements
  time frame: 3 month
  description: In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
  measure: Detect any negative effects on the TMJ
  time frame: Baseline
  description: Clinical examination of the TMJ will be done according to AAPD Guidelines. The following questionnaire will be administered to children and parents to detect any negative effects. Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
  a) Yes b) No Is there pain when chewing, talking?
  a) Yes b) No Is there pain when opening your mouth wide or yawning?
  a) Yes b) No Does biting feel uncomfortable or different from normal?
  a) Yes b) No Have you ever had locking or dislocation of the jaw?
  a) Yes b) No Is there a history of jaw, head or neck injury?
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
  measure: Detect any negative effects on the TMJ
  time frame: Immediately after treatment
  description: Clinical examination of the TMJ will be done according to AAPD Guidelines.The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
  a) Yes b) No Is there pain when chewing, talking?
  a) Yes b) No Is there pain when opening your mouth wide or yawning?
  a) Yes b) No Does biting feel uncomfortable or different from normal?
  a) Yes b) No Have you ever had locking or dislocation of the jaw?
  a) Yes b) No Is there a history of jaw, head or neck injury?
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
  measure: Detect any negative effects on the TMJ
  time frame: 1 month
  description: Clinical examination of the TMJ will be done according to AAPD Guidelines The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
  a) Yes b) No Is there pain when chewing, talking?
  a) Yes b) No Is there pain when opening your mouth wide or yawning?
  a) Yes b) No Does biting feel uncomfortable or different from normal?
  a) Yes b) No Have you ever had locking or dislocation of the jaw?
  a) Yes b) No Is there a history of jaw, head or neck injury?
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
  measure: Detect any negative effects on the TMJ
  time frame: 3 month
  description: Clinical examination of the TMJ will be done according to AAPD Guidelines The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
  a) Yes b) No Is there pain when chewing, talking?
  a) Yes b) No Is there pain when opening your mouth wide or yawning?
  a) Yes b) No Does biting feel uncomfortable or different from normal?
  a) Yes b) No Have you ever had locking or dislocation of the jaw?
  a) Yes b) No Is there a history of jaw, head or neck injury?
  a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
  a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
  measure: Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
  time frame: Baseline
  description: Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
  measure: Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
  time frame: Immediately after treatment
  description: Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects. 1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
  measure: Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
  time frame: 1 month
  description: Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
  measure: Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
  time frame: 3 month
  description: Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
  measure: Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
  time frame: 3 month
  description: Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome.
  measure: Evaluate the child's satisfaction with their HTPMC.
  time frame: 3 Month
  description: A questionnaire will be carried out through an interview with children to determine what their perception of HTPMC and the procedure is.
  I am happy with my fixed tooth
  I show my fixed tooth to my friends
  I feel happy if people ask to see my fixed tooth
  I can eat well with my fixed tooth
  My fixed tooth never hurts me
  The scale is 0 (strongly agree) 1 (agree) 2 (no opinion) 3 (disagree) 4 (strongly disagree) A higher score indicates a worse outcome.
  intervention type: Device
  intervention name: Hall Technique Prefabricated Metal Crown
  description: The Hall Technique is a type of minimally invasive dental treatment. Hall Technique involves sealing the carious lesion under a Prefabricated Metal Crown to stop its progression preventing pain and/or infection.This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 9 Years
  healthy volunteers: No
  last name: Nicola INNES, PhD
  role: Study Chair
  affiliation: Cardiff University
  last name: Bahar Melis AKYILDIZ, DDS
  phone: +905387970703
  email: baharmeliss@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Turkey
  citation: Uribe SE, Innes N, Maldupa I. The global prevalence of early childhood caries: A systematic review with meta-analysis using the WHO diagnostic criteria. Int J Paediatr Dent. 2021 Nov;31(6):817-830. doi: 10.1111/ipd.12783. Epub 2021 Apr 30.
  PMID: 33735529
  citation: Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.
  PMID: 17935593
  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: 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: Abu Serdaneh S, AlHalabi M, Kowash M, Macefield V, Khamis AH, Salami A, Hussein I. Hall technique crowns and children's masseter muscle activity: A surface electromyography pilot study. Int J Paediatr Dent. 2020 May;30(3):303-313. doi: 10.1111/ipd.12611. Epub 2020 Jan 24.
  PMID: 31894621
  citation: Shih YC, Yang R, Zou J. Assessment of occlusion and temporomandibular joint after placing preformed metal crowns on all primary molars in children. Int J Paediatr Dent. 2022 Nov;32(6):915-924. doi: 10.1111/ipd.12970. Epub 2022 May 18.
  PMID: 35484864
  citation: Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
  PMID: 31158253
  citation: Hesse D, de Araujo MP, Olegario IC, Innes N, Raggio DP, Bonifacio CC. Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:169. doi: 10.1186/s13063-016-1270-z.
  PMID: 27029801
  responsible party type: Principal Investigator
  investigator affiliation: Aydin Adnan Menderes University
  investigator full name: Melis AKYILDIZ
  investigator title: Principle investigator
  mesh term: Dental Caries