Ear, nose and throat structures in unilateral posterior crossbite patients before and after treatment compared to healthy control subjects

Nasopharyngeal lymphoid tissue, breathing pattern and articulation disorders in children with unilateral posterior crossbite: a controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15126033

Enrollment

Registered

2025-08-05

Start date

2020-06-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral posterior crossbite Oral Health

Interventions

Subjects for the UPCB group, with and without deviated oral functions or poor oral habits, will be randomly selected from a pool of prepubertal patients referred for orthodontic treatment. Prior to t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children with ULCB in the early mixed dentition period 2. Patients with all posterior teeth in crossbite (canines, primary molars and first permanent molars) that had deviated at least 2 mm unilaterally from the lower midline or had a lateral displacement of the mandible Healthy control group: No malocclusion

Exclusion criteria

Exclusion criteria: 1. Orofacial syndromes 2. Orofacial cleft patients 3. Non-cooperative participants

Design outcomes

Primary

Measure	Time frame
ENT structures, irregular orofacial functions and articulation disorders in children with ULCB in early mixed dentition and the healthy control group, assessed initially before the orthodontic treatment: Main dichotomous measures (method of measurement; scale): 1. Tongue posture (orthodontic clinical evaluation; palate-mouth floor) 2. Motor function of the tongue (ENT clinical evaluation; normal-clumsy) 3. Mentalis muscle hyperactivity (orthodontic clinical evaluation; normal-hyperactive) 4. Swallowing pattern (orthodontic clinical evaluation; somatic-visceral) 5. Articulation disorders (tripositional test; test score) 6. Patient-reported presence of allergies or frequent throat infections (questionnaire; yes-no, which?) Main ordinal measures (method of measurement; scale): 1. Eardrum condition (ENT clinical evaluation; Normal, Retracted, Exudative otitis, Acute otitis, Chronic otitis) 2. Nasal mucosa condition (ENT clinical evaluation; Normal, Swollen, Very swollen) 3. Adenoid size (ENT clinical evaluation; Small, Medium, Large) 4. Palatine tonsil size (ENT clinical evaluation; Small, Medium, Large) 5. Lip posture (ENT clinical evaluation; Closed, Pursed, Open) 6. Objective assessment of nasal breathing (ENT clinical evaluation) 7. Patient-reported snoring (questionnaire; No, Sometimes, Often) 8. Patient-reported daily (diurnal) breathing pattern (questionnaire; Nasal, Sometimes mouth, Always mouth)	—

Measure

Time frame

ENT structures, irregular orofacial functions and articulation disorders in children with ULCB in early mixed dentition and the healthy control group, assessed initially before the orthodontic treatment: Main dichotomous measures (method of measurement; scale): 1. Tongue posture (orthodontic clinical evaluation; palate-mouth floor) 2. Motor function of the tongue (ENT clinical evaluation; normal-clumsy) 3. Mentalis muscle hyperactivity (orthodontic clinical evaluation; normal-hyperactive) 4. Swallowing pattern (orthodontic clinical evaluation; somatic-visceral) 5. Articulation disorders (tripositional test; test score) 6. Patient-reported presence of allergies or frequent throat infections (questionnaire; yes-no, which?) Main ordinal measures (method of measurement; scale): 1. Eardrum condition (ENT clinical evaluation; Normal, Retracted, Exudative otitis, Acute otitis, Chronic otitis) 2. Nasal mucosa condition (ENT clinical evaluation; Normal, Swollen, Very swollen) 3. Adenoid size (ENT clinical evaluation; Small, Medium, Large) 4. Palatine tonsil size (ENT clinical evaluation; Small, Medium, Large) 5. Lip posture (ENT clinical evaluation; Closed, Pursed, Open) 6. Objective assessment of nasal breathing (ENT clinical evaluation) 7. Patient-reported snoring (questionnaire; No, Sometimes, Often) 8. Patient-reported daily (diurnal) breathing pattern (questionnaire; Nasal, Sometimes mouth, Always mouth)

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Secondary

Measure	Time frame
ENT structures and orofacial functions in ULCB children after treatment with rapid maxillary expansion compared to baseline. The same measures will be assessed 4 years after the initial examination. Main dichotomous measures (method of measurement; scale): 1. Tongue posture (orthodontic clinical evaluation; palate-mouth floor) 2. Motor function of the tongue (ENT clinical evaluation; normal-clumsy) 3. Mentalis muscle hyperactivity (orthodontic clinical evaluation; normal-hyperactive) 4. Swallowing pattern (orthodontic clinical evaluation; somatic-visceral) 5. Articulation disorders (tripositional test; test score) 6. Patient-reported presence of allergies or frequent throat infections (questionnaire; yes-no, which?) Main ordinal measures (method of measurement; scale): 1. Eardrum condition (ENT clinical evaluation; Normal, Retracted, Exudative otitis, Acute otitis, Chronic otitis) 2. Nasal mucosa condition (ENT clinical evaluation; Normal, Swollen, Very swollen) 3. Adenoid size (ENT clinical evaluation; Small, Medium, Large) 4. Palatine tonsil size (ENT clinical evaluation; Small, Medium, Large) 5. Lip posture (ENT clinical evaluation; Closed, Pursed, Open) 6. Objective assessment of nasal breathing (ENT clinical evaluation) 7. Patient-reported snoring (questionnaire; No, Sometimes, Often) 8. Patient-reported daily (diurnal) breathing pattern (questionnaire; Nasal, Sometimes mouth, Always mouth)	—

Measure

Time frame

ENT structures and orofacial functions in ULCB children after treatment with rapid maxillary expansion compared to baseline. The same measures will be assessed 4 years after the initial examination. Main dichotomous measures (method of measurement; scale): 1. Tongue posture (orthodontic clinical evaluation; palate-mouth floor) 2. Motor function of the tongue (ENT clinical evaluation; normal-clumsy) 3. Mentalis muscle hyperactivity (orthodontic clinical evaluation; normal-hyperactive) 4. Swallowing pattern (orthodontic clinical evaluation; somatic-visceral) 5. Articulation disorders (tripositional test; test score) 6. Patient-reported presence of allergies or frequent throat infections (questionnaire; yes-no, which?) Main ordinal measures (method of measurement; scale): 1. Eardrum condition (ENT clinical evaluation; Normal, Retracted, Exudative otitis, Acute otitis, Chronic otitis) 2. Nasal mucosa condition (ENT clinical evaluation; Normal, Swollen, Very swollen) 3. Adenoid size (ENT clinical evaluation; Small, Medium, Large) 4. Palatine tonsil size (ENT clinical evaluation; Small, Medium, Large) 5. Lip posture (ENT clinical evaluation; Closed, Pursed, Open) 6. Objective assessment of nasal breathing (ENT clinical evaluation) 7. Patient-reported snoring (questionnaire; No, Sometimes, Often) 8. Patient-reported daily (diurnal) breathing pattern (questionnaire; Nasal, Sometimes mouth, Always mouth)

—

Countries

Slovenia

Contacts

Public ContactAljaz Golez

aljaz.golez@mf.uni-lj.si+386 (0)15437511

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026