NCT07161401

Brief Summary

This observational cross-sectional study evaluated the impact of sagittal skeletal malocclusions on sleep quality in children without orofacial functional disorders. A total of 164 children aged 7-13 years were assessed. Sleep quality was measured using the Children's Sleep Habits Questionnaire (CSHQ), and participants were classified as skeletal Class I, II, or III based on cephalometric analyses. Comparisons were made between skeletal groups regarding CSHQ scores, mandibular and vertical skeletal measurements, and upper airway dimensions. The aim was to determine whether skeletal discrepancies independently influence pediatric sleep quality in the absence of functional impairments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

August 30, 2025

Last Update Submit

August 30, 2025

Conditions

Keywords

Pediatric sleep

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality (CSHQ Score)

    Sleep quality was assessed using the Children's Sleep Habits Questionnaire (CSHQ), a validated parent-reported tool. Higher total scores indicate poorer sleep quality.

    At baseline (single assessment)

Study Arms (3)

Group 1: Skeletal Class I

Participants with skeletal Class I malocclusion based on ANB angle.

Other: Observational assessment

Group 2: Skeletal Class II

Participants with skeletal Class II malocclusion based on ANB angle.

Other: Observational assessment

Group 3: Skeletal Class III

Participants with skeletal Class III malocclusion based on ANB angle.

Other: Observational assessment

Interventions

Evaluation of sleep quality using the Children's Sleep Habits Questionnaire (CSHQ) and cephalometric analysis of mandibular position (SNB), vertical dimensions (SNGoGn, FMA), and upper airway measurements. No active intervention was performed.

Group 1: Skeletal Class IGroup 2: Skeletal Class IIGroup 3: Skeletal Class III

Eligibility Criteria

Age7 Days - 13 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of children aged 7-13 years presenting with skeletal Class I, II, or III malocclusion. Only patients without systemic diseases, orofacial functional disorders, previous orthodontic treatment, or craniofacial anomalies were included

You may qualify if:

  • Children aged 7-13 years
  • Presence of skeletal Class I, II, or III malocclusion (based on ANB angle)
  • Written informed parental consent

You may not qualify if:

  • Presence of systemic diseases
  • Current use of medications such as anticonvulsants, immunosuppressants, or calcium channel blockers
  • Exposure to stressful life events within the past month
  • Presence of deleterious oral habits (e.g., thumb sucking, mouth breathing, infantile swallowing)
  • Signs of tonsillar hypertrophy, nasal deviation, nasal polyps, or adenoid vegetation
  • Diagnosis of sleep-disordered breathing (SDB)
  • History of orofacial surgery or orthodontic treatment
  • Presence of craniofacial anomalies (e.g., cleft lip/palate, syndromes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uşak University, Faculty of Dentistry, Department of Orthodontics

Uşak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Orthodontics, Faculty of Dentistry, Dokuz Eylül University

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

April 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations