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Bruxism, SleepNCT03833505

Enterobius Vermicularis and Bruxism in Children

An observational study of Bruxism, Sleep, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Bruxism, Sleep
What is being tested?
Bitestrip
Type of treatment
Pill or oral medicine
How many people
26 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2017to 15 Aug 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 10 years
  • All sexes
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry

    Aydin

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Relationship Between Enterobius Vermicularis Infection and Bruxism in Children

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.

Read the 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.

Conditions
Bruxism, Sleep
Being tested
Bitestrip
Medical subject headings
Sleep Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BitestripOther

    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.

Study groups in NCT03833505
Study groupRoleWhat they receive
Group 1,E. vermicularis-positive
Receives: Other: Bitestrip
Group 2E. vermicularis-negative
Receives: Other: Bitestrip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survey

    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.

    Measured: 24.03.2017-20.05.2018

Secondary outcomes (1)

  1. Oral examination

    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).

    Measured: 24.03.2017-20.05.2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2019
  2. Study start15 Mar 2017
  3. Primary completion20 May 2018
  4. Study completion15 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833505
Sponsor's protocol ID
2017/003-24.03.2017
Status last verified
Feb 2019
First submitted
5 Jan 2019
Last updated
7 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19040814

  • 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.

    PubMed 20567031

  • 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.

    PubMed 22013457

  • 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.

    PubMed 27134350

  • 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.

    PubMed 17618147

  • 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.

    PubMed 21916926

  • 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.

    PubMed 8468624

  • 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.

    PubMed 25547142

  • 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.

    PubMed 9204506

  • 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.

    PubMed 24843394

Questions about this trial

What is this clinical trial studying?

An observational study of Bruxism, Sleep, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survey (time frame: 24.03.2017-20.05.2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03833505, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.

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