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Enterobius Vermicularis and Bruxism in Children

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ClinicalTrials.gov Identifier: NCT03833505
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Kadriye Görkem Ulu Güzel, Aydin Adnan Menderes University

Brief Summary:

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.


Condition or disease Intervention/treatment
Bruxism, Sleep Other: Bitestrip

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Relationship Between Enterobius Vermicularis Infection and Bruxism in Children
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : May 20, 2018
Actual Study Completion Date : August 15, 2018

Group/Cohort Intervention/treatment
Group 1,
E. vermicularis-positive
Other: Bitestrip
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.

Group 2
E. vermicularis-negative
Other: Bitestrip
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.




Primary Outcome Measures :
  1. Survey [ Time Frame: 24.03.2017-20.05.2018 ]
    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.


Secondary Outcome Measures :
  1. Oral examination [ Time Frame: 24.03.2017-20.05.2018 ]
    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).


Other Outcome Measures:
  1. BiteStrip [ Time Frame: 24.03.2017-20.05.2018 ]
    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.



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study included E. vermicularis-positive (Group 1, n =13) and E. vermicularis-negative (Group 2: n = 13) children aged between 3-10 years, who were admitted to Aydın Adnan Menderes University Faculty of Medicine Paediatric Gastroenterology Clinic.
Criteria

Inclusion Criteria:

  • Teeth-grinding at least once a week in the last 3 months before recruitment according to the criteria established by the American Academy of Sleep Medicine (AASM)
  • Angle class I occlusion
  • Mesial step occlusion according to flush terminal plane.

Exclusion Criteria:

  • Treated with anti-helminthic drugs in the last 2 months before recruitment
  • Drugs used that could affect the central nervous system and prevent sleep (sedatives, anti-depressants, neuroleptics, anti-muscarinics, selective serotonin re-uptake inhibitors)
  • Sleep disorders (snoring, insomnia, obstructive sleep apnoea, restless leg syndrome, sleep-related epilepsy)
  • Psychiatric or neurological disorders
  • Upper respiratory system obstruction (last 15 days),
  • Any systemic disease;
  • Teeth erosion due to internal (reflux) or external (acidic drinks) factors
  • Dermatological problems, associated with the use of BiteStrip (Up2dent, Inc., Pulheim, Germany);
  • Unsuitable skin structure;
  • Previously diagnosed and treated for bruxism;
  • Angle class II or class III occlusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833505


Locations
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Turkey
Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry
Aydın, Turkey
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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Study Director: K. Görkem Ulu Güzel ADU Faculty of Dentistry Paediatric Dentistry Department

Publications of Results:
Other Publications:

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Responsible Party: Kadriye Görkem Ulu Güzel, Assistant Prof, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03833505     History of Changes
Other Study ID Numbers: 2017/003-24.03.2017
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders