NCT03833505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

January 5, 2019

Last Update Submit

February 6, 2019

Conditions

Bruxism, Sleep

Outcome Measures

Primary Outcomes (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.

    24.03.2017-20.05.2018

Secondary Outcomes (1)

  • Oral examination

    24.03.2017-20.05.2018

Other Outcomes (1)

  • BiteStrip

    24.03.2017-20.05.2018

Study Arms (2)

Group 1,

E. vermicularis-positive

Other: Bitestrip

Group 2

E. vermicularis-negative

Other: Bitestrip

Interventions

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.

Group 1,Group 2

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aydin, Turkey (Türkiye)

Location

Related Publications (10)

  • 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: 19040814BACKGROUND

  • 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.

    PMID: 20567031BACKGROUND

  • 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: 22013457BACKGROUND

  • 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: 27134350BACKGROUND

  • 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: 17618147BACKGROUND

  • 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: 21916926BACKGROUND

  • 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: 8468624BACKGROUND

  • 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: 25547142BACKGROUND

  • 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: 9204506BACKGROUND

  • 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: 24843394RESULT

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • K. Görkem Ulu Güzel

    ADU Faculty of Dentistry Paediatric Dentistry Department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof

Study Record Dates

First Submitted

January 5, 2019

First Posted

February 7, 2019

Study Start

March 15, 2017

Primary Completion

May 20, 2018

Study Completion

August 15, 2018

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)