NCT06259786

Brief Summary

The aim of this study is to examine the effects of bruxism on mandibular movement capacity, cervical proprioception, posture and quality of life in adolescents diagnosed with nocturnal bruxism (clenching and grinding teeth while sleeping) between the ages of 13-18 and to compare them with healthy adolescents. Method: A total of 40 adolescents, 20 with nocturnal bruxism and 20 healthy, will be included in the study. Mandibular movement capacity will be evaluated with a caliper and ruler, cervical proprioception with a CROM device, posture with the New York Posture Scale, and quality of life with the PedsQL 13-18 age scale. Hypotheses: H1: Nocturnal bruxism reduces the movement capacity of the mandible in adolescents. H2: Nocturnal bruxism reduces cervical proprioception in adolescents. H3: Posture disorder increases in adolescents with nocturnal bruxism. H4: Nocturnal bruxism affects the level of daily life quality in adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

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

February 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

28 days

First QC Date

February 6, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

Nocturnal BruxismPostureLife QualityCervical ProprioceptionAdolescent

Outcome Measures

Primary Outcomes (1)

  • Mandibular movement capacity

    For the movement capacity of the mandible, maximum mouth opening is measured using a caliper device, and right/left lateral movement (laterotrusion) and forward movement (protrusion) are measured using a linear ruler. During the evaluation, the incisal distance is determined as the reference point between the maxillary and mandibular central incisors and is recorded in millimeters (mm). These measurements provide detailed information about the movement capacity of the mandible.

    First Day

Secondary Outcomes (3)

  • Cervical proprioception

    First Day

  • New York Posture Scale

    First Day

  • Pediatric quality of life questionnaire

    First day

Study Arms (2)

Nocturnal Bruxism

The Quality of Life (The Pediatric Quality of Life Inventory - PedsQL), Postural Changes (New York Posture Analysis - NYPA), Cervical Proprioception (CROM Device), Mandibular Movement Capacity (Maximum Mouth Opening - The Caliper and Excursions- The Linear Rule) will be evaluated.

Healthy Group

The Quality of Life (The Pediatric Quality of Life Inventory - PedsQL), Postural Changes (New York Posture Analysis - NYPA), Cervical Proprioception (CROM Device), Mandibular Movement Capacity (Maximum Mouth Opening - The Caliper and Excursions- The Linear Ruler) will be evaluated.

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 patients with Nocturnal Bruxism and 20 non-Nocturnal Bruxism Adolescence will be included.

You may qualify if:

  • Being diagnosed with nocturnal bruxism,
  • Having received parental consent to participate in the study,
  • Being between the ages of 13 and 18 (including 13,18 years old)
  • Being in good mental state,
  • Being able to understand and follow the locations in the work,
  • Having a Class 1 occlusion.

You may not qualify if:

  • Not consenting to participate in the study and withdrawing from the study,
  • Not being able to cooperate well,
  • Having a history of surgery,
  • Having any physical disability or chronic disease,
  • Having received dental treatment in the last six months,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, 78000, Turkey (Türkiye)

Location

Related Publications (7)

  • Manfredini D, Restrepo C, Diaz-Serrano K, Winocur E, Lobbezoo F. Prevalence of sleep bruxism in children: a systematic review of the literature. J Oral Rehabil. 2013 Aug;40(8):631-42. doi: 10.1111/joor.12069. Epub 2013 May 24.

    PMID: 23700983BACKGROUND
  • Manfredini D, Lobbezoo F. Role of psychosocial factors in the etiology of bruxism. J Orofac Pain. 2009 Spring;23(2):153-66.

    PMID: 19492540BACKGROUND
  • Serra-Negra JM, Paiva SM, Auad SM, Ramos-Jorge ML, Pordeus IA. Signs, symptoms, parafunctions and associated factors of parent-reported sleep bruxism in children: a case-control study. Braz Dent J. 2012;23(6):746-52. doi: 10.1590/s0103-64402012000600020.

    PMID: 23338271BACKGROUND
  • de Oliveira Reis L, Ribeiro RA, Martins CC, Devito KL. Association between bruxism and temporomandibular disorders in children: A systematic review and meta-analysis. Int J Paediatr Dent. 2019 Sep;29(5):585-595. doi: 10.1111/ipd.12496. Epub 2019 Apr 15.

    PMID: 30888712BACKGROUND
  • Cakin Memik N, Agaoglu B, Coskun A, Uneri OS, Karakaya I. [The validity and reliability of the Turkish Pediatric Quality of Life Inventory for children 13-18 years old]. Turk Psikiyatri Derg. 2007 Winter;18(4):353-63. Turkish.

    PMID: 18066726BACKGROUND
  • Fletcher JP, Bandy WD. Intrarater reliability of CROM measurement of cervical spine active range of motion in persons with and without neck pain. J Orthop Sports Phys Ther. 2008 Oct;38(10):640-5. doi: 10.2519/jospt.2008.2680.

    PMID: 18827326BACKGROUND
  • Sanches ML, Juliano Y, Novo NF, Guimaraes AS, Rodrigues Conti PC, Alonso LG. Correlation between pressure pain threshold and pain intensity in patients with temporomandibular disorders who are compliant or non-compliant with conservative treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Oct;120(4):459-68. doi: 10.1016/j.oooo.2015.05.017. Epub 2015 May 29.

    PMID: 26188733BACKGROUND

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Feruza JUMAYEVA Physiotherapist

    Karabuk University

    STUDY CHAIR
  • Musa GÜNEŞ MsC

    Karabuk University

    STUDY DIRECTOR
  • Metehan YANA PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Kader AZLAĞ PEKİNCE PhD

    Karabuk University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

February 1, 2024

Primary Completion

February 29, 2024

Study Completion

March 29, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations