<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/NCT03833505</url>
  </required_header>
  <id_info>
    <org_study_id>2017/003-24.03.2017</org_study_id>
    <nct_id>NCT03833505</nct_id>
  </id_info>
  <brief_title>Enterobius Vermicularis and Bruxism in Children</brief_title>
  <official_title>Evaluation of Relationship Between Enterobius Vermicularis Infection and Bruxism in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aydin Adnan Menderes University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background. Bruxism is an involuntary, non-functional activity of the masticatory system, and&#xD;
      is frequently seen in childhood. Bruxism has many aetiologies, like malocclusion,&#xD;
      psychological factors, allergies and gastrointestinal disorders.&#xD;
&#xD;
      Aim. To investigate the relationship between Enterobius vermicularis infection and bruxism in&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bruxism has many aetiologies, like occlusal interferences, malocclusion, malnutrition,&#xD;
      psychological factors, allergies and gastrointestinal disorders. Among these gastrointestinal&#xD;
      disorders, are various intestinal parasitic infections.&#xD;
&#xD;
      Given the controversy surrounding the potential association between bruxism and intestinal&#xD;
      parasitic infestations, both important health issues, this study sought to evaluate the&#xD;
      relationship between E. vermicularis infection and bruxism in E. vermicularis-positive and E.&#xD;
      vermicularis-negative 3-10-year-olds children with bruxism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">May 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survey</measure>
    <time_frame>24.03.2017-20.05.2018</time_frame>
    <description>The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. vermicularis and bruxism, other harmful oral habits, family life and habits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral examination</measure>
    <time_frame>24.03.2017-20.05.2018</time_frame>
    <description>The patients who had a teeth-grinding habit were invited to, our clinic for clinical evaluation of bruxism. Patients were examined under a reflector light with inspection, palpation and mirror-sond. The extraoral examination evaluated mandibular asymmetry, joint sounds, deviation/deflection during opening/closing actions, sensitivity to palpation of masticatory muscles and pain/tenderness, sensitivity to palpation of the temporomandibular joint and masseter muscle hypertrophy10. The intraoral examination assessed the presence of wear facets on the teeth, according to a modification of the method by Johansson. The assessed teeth included primary incisors, canines and molars, permanent incisors and lower first molars. Scores were calculated as follows: 0 = no wear (none); 1 = enamel wear only (mild); 2 = enamel and dentin wear (moderate); 3 = significant loss of tooth structure (severe).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BiteStrip</measure>
    <time_frame>24.03.2017-20.05.2018</time_frame>
    <description>For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Bruxism, Sleep</condition>
  <arm_group>
    <arm_group_label>Group 1,</arm_group_label>
    <description>E. vermicularis-positive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>E. vermicularis-negative</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bitestrip</intervention_name>
    <description>The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep and bruxism, other harmful oral habits, family life and habits.</description>
    <arm_group_label>Group 1,</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included E. vermicularis-positive (Group 1, n =13) and E. vermicularis-negative&#xD;
        (Group 2: n = 13) children aged between 3-10 years, who were admitted to Aydın Adnan&#xD;
        Menderes University Faculty of Medicine Paediatric Gastroenterology Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Teeth-grinding at least once a week in the last 3 months before recruitment according&#xD;
             to the criteria established by the American Academy of Sleep Medicine (AASM)&#xD;
&#xD;
          -  Angle class I occlusion&#xD;
&#xD;
          -  Mesial step occlusion according to flush terminal plane.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treated with anti-helminthic drugs in the last 2 months before recruitment&#xD;
&#xD;
          -  Drugs used that could affect the central nervous system and prevent sleep (sedatives,&#xD;
             anti-depressants, neuroleptics, anti-muscarinics, selective serotonin re-uptake&#xD;
             inhibitors)&#xD;
&#xD;
          -  Sleep disorders (snoring, insomnia, obstructive sleep apnoea, restless leg syndrome,&#xD;
             sleep-related epilepsy)&#xD;
&#xD;
          -  Psychiatric or neurological disorders&#xD;
&#xD;
          -  Upper respiratory system obstruction (last 15 days),&#xD;
&#xD;
          -  Any systemic disease;&#xD;
&#xD;
          -  Teeth erosion due to internal (reflux) or external (acidic drinks) factors&#xD;
&#xD;
          -  Dermatological problems, associated with the use of BiteStrip (Up2dent, Inc., Pulheim,&#xD;
             Germany);&#xD;
&#xD;
          -  Unsuitable skin structure;&#xD;
&#xD;
          -  Previously diagnosed and treated for bruxism;&#xD;
&#xD;
          -  Angle class II or class III occlusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>K. Görkem Ulu Güzel</last_name>
    <role>Study Director</role>
    <affiliation>ADU Faculty of Dentistry Paediatric Dentistry Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry</name>
      <address>
        <city>Aydın</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Diaz-Serrano KV, da Silva CB, de Albuquerque S, Pereira Saraiva Mda C, Nelson-Filho P. Is there an association between bruxism and intestinal parasitic infestation in children? J Dent Child (Chic). 2008 Sep-Dec;75(3):276-9.</citation>
    <PMID>19040814</PMID>
  </reference>
  <reference>
    <citation>Mistry P, Moles DR, O'Neill J, Noar J. The occlusal effects of digit sucking habits amongst school children in Northamptonshire (UK). J Orthod. 2010 Jun;37(2):87-92. doi: 10.1179/14653121042939. Erratum In: J Orthod. 2010 Dec;37(4):319.</citation>
    <PMID>20567031</PMID>
  </reference>
  <reference>
    <citation>Tehrani MH, Pestechian N, Yousefi H, Sekhavati H, Attarzadeh H. The Correlation between Intestinal Parasitic Infections and Bruxism among 3-6 Year-Old Children in Isfahan. Dent Res J (Isfahan). 2010 Summer;7(2):51-5.</citation>
    <PMID>22013457</PMID>
  </reference>
  <reference>
    <citation>Bortoletto CC, Cordeiro da Silva F, Salgueiro Mda C, Motta LJ, Curiki LM, Mesquita-Ferarri RA, Fernandes KP, Bussadori SK. Evaluation of electromyographic signals in children with bruxism before and after therapy with Melissa Officinalis L-a randomized controlled clinical trial. J Phys Ther Sci. 2016 Mar;28(3):738-42. doi: 10.1589/jpts.28.738. Epub 2016 Mar 31.</citation>
    <PMID>27134350</PMID>
  </reference>
  <reference>
    <citation>Shochat T, Gavish A, Arons E, Hadas N, Molotsky A, Lavie P, Oksenberg A. Validation of the BiteStrip screener for sleep bruxism. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Sep;104(3):e32-9. doi: 10.1016/j.tripleo.2007.03.009. Epub 2007 Jul 6.</citation>
    <PMID>17618147</PMID>
  </reference>
  <reference>
    <citation>Emodi-Perlman A, Eli I, Friedman-Rubin P, Goldsmith C, Reiter S, Winocur E. Bruxism, oral parafunctions, anamnestic and clinical findings of temporomandibular disorders in children. J Oral Rehabil. 2012 Feb;39(2):126-35. doi: 10.1111/j.1365-2842.2011.02254.x. Epub 2011 Sep 15.</citation>
    <PMID>21916926</PMID>
  </reference>
  <reference>
    <citation>Johansson A, Haraldson T, Omar R, Kiliaridis S, Carlsson GE. A system for assessing the severity and progression of occlusal tooth wear. J Oral Rehabil. 1993 Mar;20(2):125-31. doi: 10.1111/j.1365-2842.1993.tb01596.x.</citation>
    <PMID>8468624</PMID>
  </reference>
  <reference>
    <citation>Karakis D, Dogan A. The craniofacial morphology and maximum bite force in sleep bruxism patients with signs and symptoms of temporomandibular disorders. Cranio. 2015 Jan;33(1):32-7. doi: 10.1179/2151090314Y.0000000009. Epub 2014 Jun 3.</citation>
    <PMID>25547142</PMID>
  </reference>
  <reference>
    <citation>Van Wyk JA, Van Rensburg LJ, Heitmann LP. Schistosoma mattheei infection in cattle: the course of the intestinal syndrome, and an estimate of the lethal dose of cercariae. Onderstepoort J Vet Res. 1997 Mar;64(1):65-75.</citation>
    <PMID>9204506</PMID>
  </reference>
  <results_reference>
    <citation>Karakis D, Dogan A, Bek B. Evaluation of the effect of two different occlusal splints on maximum occlusal force in patients with sleep bruxism: a pilot study. J Adv Prosthodont. 2014 Apr;6(2):103-8. doi: 10.4047/jap.2014.6.2.103. Epub 2014 Apr 22.</citation>
    <PMID>24843394</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
    <investigator_full_name>Kadriye Görkem Ulu Güzel</investigator_full_name>
    <investigator_title>Assistant Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
    <mesh_term>Sleep Bruxism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03833505
org study id: 2017/003-24.03.2017
nct id: NCT03833505
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Background. Bruxism is an involuntary, non-functional activity of the masticatory system, and
      is frequently seen in childhood. Bruxism has many aetiologies, like malocclusion,
      psychological factors, allergies and gastrointestinal disorders.

      Aim. To investigate the relationship between Enterobius vermicularis infection and bruxism in
      children.
Bruxism has many aetiologies, like occlusal interferences, malocclusion, malnutrition,
      psychological factors, allergies and gastrointestinal disorders. Among these gastrointestinal
      disorders, are various intestinal parasitic infections.

      Given the controversy surrounding the potential association between bruxism and intestinal
      parasitic infestations, both important health issues, this study sought to evaluate the
      relationship between E. vermicularis infection and bruxism in E. vermicularis-positive and E.
      vermicularis-negative 3-10-year-olds children with bruxism.
observational model: Other
time perspective: Cross-Sectional
measure: Survey
time frame: 24.03.2017-20.05.2018
description: The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. vermicularis and bruxism, other harmful oral habits, family life and habits.
measure: Oral examination
time frame: 24.03.2017-20.05.2018
description: The patients who had a teeth-grinding habit were invited to, our clinic for clinical evaluation of bruxism. Patients were examined under a reflector light with inspection, palpation and mirror-sond. The extraoral examination evaluated mandibular asymmetry, joint sounds, deviation/deflection during opening/closing actions, sensitivity to palpation of masticatory muscles and pain/tenderness, sensitivity to palpation of the temporomandibular joint and masseter muscle hypertrophy10. The intraoral examination assessed the presence of wear facets on the teeth, according to a modification of the method by Johansson. The assessed teeth included primary incisors, canines and molars, permanent incisors and lower first molars. Scores were calculated as follows: 0 = no wear (none); 1 = enamel wear only (mild); 2 = enamel and dentin wear (moderate); 3 = significant loss of tooth structure (severe).
measure: BiteStrip
time frame: 24.03.2017-20.05.2018
description: For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep.
arm group label: Group 1,
description: E. vermicularis-positive
arm group label: Group 2
description: E. vermicularis-negative
intervention type: Other
intervention name: Bitestrip
description: The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep and bruxism, other harmful oral habits, family life and habits.
arm group label: Group 1,
arm group label: Group 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
last name: K. Görkem Ulu Güzel
role: Study Director
affiliation: ADU Faculty of Dentistry Paediatric Dentistry Department
facility: 
country: Turkey
citation: Diaz-Serrano KV, da Silva CB, de Albuquerque S, Pereira Saraiva Mda C, Nelson-Filho P. Is there an association between bruxism and intestinal parasitic infestation in children? J Dent Child (Chic). 2008 Sep-Dec;75(3):276-9.
PMID: 19040814
citation: Mistry P, Moles DR, O'Neill J, Noar J. The occlusal effects of digit sucking habits amongst school children in Northamptonshire (UK). J Orthod. 2010 Jun;37(2):87-92. doi: 10.1179/14653121042939. Erratum In: J Orthod. 2010 Dec;37(4):319.
PMID: 20567031
citation: Tehrani MH, Pestechian N, Yousefi H, Sekhavati H, Attarzadeh H. The Correlation between Intestinal Parasitic Infections and Bruxism among 3-6 Year-Old Children in Isfahan. Dent Res J (Isfahan). 2010 Summer;7(2):51-5.
PMID: 22013457
citation: Bortoletto CC, Cordeiro da Silva F, Salgueiro Mda C, Motta LJ, Curiki LM, Mesquita-Ferarri RA, Fernandes KP, Bussadori SK. Evaluation of electromyographic signals in children with bruxism before and after therapy with Melissa Officinalis L-a randomized controlled clinical trial. J Phys Ther Sci. 2016 Mar;28(3):738-42. doi: 10.1589/jpts.28.738. Epub 2016 Mar 31.
PMID: 27134350
citation: Shochat T, Gavish A, Arons E, Hadas N, Molotsky A, Lavie P, Oksenberg A. Validation of the BiteStrip screener for sleep bruxism. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Sep;104(3):e32-9. doi: 10.1016/j.tripleo.2007.03.009. Epub 2007 Jul 6.
PMID: 17618147
citation: Emodi-Perlman A, Eli I, Friedman-Rubin P, Goldsmith C, Reiter S, Winocur E. Bruxism, oral parafunctions, anamnestic and clinical findings of temporomandibular disorders in children. J Oral Rehabil. 2012 Feb;39(2):126-35. doi: 10.1111/j.1365-2842.2011.02254.x. Epub 2011 Sep 15.
PMID: 21916926
citation: Johansson A, Haraldson T, Omar R, Kiliaridis S, Carlsson GE. A system for assessing the severity and progression of occlusal tooth wear. J Oral Rehabil. 1993 Mar;20(2):125-31. doi: 10.1111/j.1365-2842.1993.tb01596.x.
PMID: 8468624
citation: Karakis D, Dogan A. The craniofacial morphology and maximum bite force in sleep bruxism patients with signs and symptoms of temporomandibular disorders. Cranio. 2015 Jan;33(1):32-7. doi: 10.1179/2151090314Y.0000000009. Epub 2014 Jun 3.
PMID: 25547142
citation: Van Wyk JA, Van Rensburg LJ, Heitmann LP. Schistosoma mattheei infection in cattle: the course of the intestinal syndrome, and an estimate of the lethal dose of cercariae. Onderstepoort J Vet Res. 1997 Mar;64(1):65-75.
PMID: 9204506
citation: Karakis D, Dogan A, Bek B. Evaluation of the effect of two different occlusal splints on maximum occlusal force in patients with sleep bruxism: a pilot study. J Adv Prosthodont. 2014 Apr;6(2):103-8. doi: 10.4047/jap.2014.6.2.103. Epub 2014 Apr 22.
PMID: 24843394
responsible party type: Principal Investigator
investigator affiliation: Aydin Adnan Menderes University
investigator full name: Kadriye Görkem Ulu Güzel
investigator title: Assistant Prof
mesh term: Bruxism
mesh term: Sleep Bruxism
sharing ipd: No