Effect of rapid maxillary expansion on glenoid fossa and condylar position in growing patients

Effect of rapid Maxillary Expansion on glenoid fossa and condyle-fossa relationship in Growing Patients: Study protocol for a controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77788053

Enrollment

Registered

2017-11-07

Start date

2016-09-01

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

Growing subjects, aged 8 to 13 years presenting a transverse maxillary skeletal deficiency, with bilateral crossbite involving one or more posterior teeth Oral Health Transverse maxillary skeletal deficiency, with bilateral crossbite involving one or more posterior teeth

Interventions

At baseline, all the patients undergo clinical examination, plaster study model casts and maxillary low-dose 3D CBCT (Cone-beam computed tomography) with an iCat® machine (Imaging Sciences Internation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female growing subject 2. Aged 8 to 13 years 3. Presence of a transverse maxillary skeletal deficiency, with bilateral crossbite involving one or more posterior teeth (bicuspids or molars) assessed by a clinical examination 4. Presence of sufficient crown length (around 3-4mms) to provide the necessary anchorage for the RME appliance selected for the study 5. Presence of a deep palatal vault 6. Dental crowding at the start of treatment

Exclusion criteria

Exclusion criteria: 1. Craniofacial syndromes (such as craniosynostosis, Apert-Crouzon, Treacher-Collins, orofacial clefting, etc.) 2. Missing maxillary posterior permanent teeth (first molars) 3. Concomitant periodontal disease 4. Previous orthodontic treatment

Design outcomes

Primary

Measure	Time frame
Interglenoid fossa distance is measured using specific software (ITK-SNAP, IMAGINE, CMF) at baseline and 6-month visit. All the outcomes are radiological. Radiological data acquired with CBCT obtained at baseline and 6 months will be saved as DICOM files. 3-dimensional surface models of the anatomic structures will be built using specific software (ITK-SNAP; open-source software, www.itksnap.org; IMAGINE, open-source software, http://www.ia.unc.edu/dev/download/imagine , Cranio-Maxillo-Facial (CMF) application software, M. E. Müller Institute for Surgical Technology and Biomechanics, University of Bern, http://co-me.ch ).	—

Measure

Time frame

Interglenoid fossa distance is measured using specific software (ITK-SNAP, IMAGINE, CMF) at baseline and 6-month visit. All the outcomes are radiological. Radiological data acquired with CBCT obtained at baseline and 6 months will be saved as DICOM files. 3-dimensional surface models of the anatomic structures will be built using specific software (ITK-SNAP; open-source software, www.itksnap.org; IMAGINE, open-source software, http://www.ia.unc.edu/dev/download/imagine , Cranio-Maxillo-Facial (CMF) application software, M. E. Müller Institute for Surgical Technology and Biomechanics, University of Bern, http://co-me.ch ).

—

Secondary

Measure	Time frame
1. Condyle fossa relationships are measured using specific software (ITK-SNAP, IMAGINE, CMF) at baseline and 6-month visit 2. 3D condylar angles are measured using specific software (ITK-SNAP, IMAGINE, CMF) at baseline and 6-month visit 3. Nasal width is measured using specific software (ITK-SNAP, IMAGINE, CMF) at baseline and 6-month visit	—

Countries

Lebanon

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026