Actively Recruiting

Phase Not Applicable
Age: 10Years - 12Years
All Genders
Healthy Volunteers
ID07548502

Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals

Led by Nigde Omer Halisdemir University · Updated on 2026-04-29

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying bruxism, a condition involving teeth grinding, in children aged 10 to 12 years. This study aims to examine clinical signs of bruxism and measure the thickness of the masseter muscle using ultrasound imaging. It also evaluates how wearing a custom-made night guard at night affects these clinical findings and muscle thickness over time. Participants will receive a custom-made night guard designed to be worn during sleep. The study involves a single group of 20 children diagnosed with bruxism based on parents' reports and clinical exams. Muscle thickness measurements will be taken on both sides of the face at the start of the study, at 3 months, and again at 6 months. Clinical symptoms like tooth wear, muscle tenderness, jaw joint issues, and habits will be monitored throughout. Children will be assessed at three time points: baseline, 3 months, and 6 months. Ultrasonography will be performed using a standardized method by a specialist. Pain levels will be recorded using the Wong-Baker Faces Pain Rating Scale, and jaw joint function will be evaluated by checking for joint sounds, movement deviations, and tenderness. The study is non-invasive, without radiation, and participation lasts about six months.

CONDITIONS

Brief Title

Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism

Who Can Participate

Age: 10Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 10-12 years
  • Diagnosis of bruxism based on parental report and clinical findings
  • Willingness to participate
  • Parental consent and child assent obtained
Not Eligible

You will not qualify if you...

  • Missing posterior teeth causing unilateral chewing
  • History of psychological disorders
  • Neurological disorders or craniofacial abnormalities
  • Use of medications affecting muscle activity
  • Presence of skeletal malocclusions
  • Ongoing orthodontic treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive a custom-made night guard and are instructed to use it regularly during sleep. Clinical symptoms and masseter muscle thickness are assessed over time.

3 visits at baseline, 3 months, and 6 months (in-person)

Trial Site Locations

Total: 1 location

1

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, Turkey (Türkiye)

Actively Recruiting

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Research Team

A

Aycan Dal Dönertaş

S

Serkan Yılmaz

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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