Health TrialsbyHealthPanel

Clear Orthodontic Expander Versus Hyrax

ConditionsMalocclusionNarrow Maxilla
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorUniversity of Baghdad

About this trial

This study will be conducted to evaluate the effectiveness of a clear expander fabricated from 2-mm biocompatible polyethylene terephthalate glycol (PETG) thermoforming material integrated with an expansion screw in achieving dental and skeletal expansion in adolescent patients, compared with the conventional Hyrax expander.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients' age at the start of treatment will range from 10-14 years.

Unstable unilateral or bilateral posterior crossbite due to maxillary constriction.

The first molars are fully erupted.

Good oral health free from caries and periodontal problems at the start of treatment.

Disqualifiers

Patients with obvious facial asymmetry.

Patients with orofacial cleft.

Patients with previous orthodontic treatment.

Patients with bad oral habits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • New clear expander

    Device

    All patients with a clear expander will be instructed to wear the appliance 24 hours a day, except during eating and cleaning. The expander will be activated twice daily (0.2 mm per turn). Patients will be provided with an instruction brochure and advised to use a reminder to ensure compliance. The expansion will continue until the desired amount of the maxillary arch expansion occurs when the maxillary first molars' palatal cusps occlude the lingual side of the mandibular first molar buccal cusps to overcome the expected relapse due to the elasticity of the palatal soft tissue.

  • Hyrax expander

    Device

    The activation protocol for the Hyrax expander will be the same in all patients, twice daily (0.2 mm per turn). The expansion will continue until the desired amount of the maxillary arch expansion occurs when the maxillary first molars' palatal cusps occlude the lingual side of the mandibular first molar buccal cusps to overcome the expected relapse due to the elasticity of the palatal soft tissue.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: New clear expanderExperimental treatment 1 intervention
Group B: Hyrax expanderExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CBCT evaluation

Skeletal and dentoalveolar measurements will be assessed using cone-beam computed tomography (CBCT). Skeletal measurements will include nasal width, midpalatal suture gap, and palatal height, measured in millimeters (mm). Dentoalveolar measurements will include vertical dental heights and maxillary width measured in millimeters (mm), as well as dental inclination measured in degrees (°). All measurements will be obtained from CBCT images using dedicated three-dimensional imaging analysis software.

Time frame
pre-treatment (T0) and immediately post-treatment (T1) around one to two months

Secondary outcomes

1

Intraoral scan of the maxillary arch evaluation

Maxillary transverse dental measurements will be assessed using a digital intraoral scan. The parameters evaluated will include intercanine width, interpremolar width, intermolar width, and intermolar transpalatal width, all measured in millimeters (mm) using three-dimensional digital dental model analysis software.

Time frame
pre-treatment (T0) and post-treatment (T1) around one to two months
2

Clinical evaluation

Overjet and overbite will be evaluated clinically using a calibrated orthodontic ruler, with measurements recorded in millimeters (mm).

Time frame
pre-treatment (T0) and immediately post-treatment (T1) around one to two months
3

Cephalometric analysis

CBCT-derived cephalometric images will be used to measure the maxillary mandibular plane angle in degrees (°) to evaluate the vertical relationship using cephalometric analysis software.

Time frame
pre-treatment (T0) and immediately post-treatment (T1) around one to two months
4

Microbial evaluation

Patients will be allocated into two groups according to the cleaning method: brushing with a toothbrush and aligner foam (China) or using Efferdent cleaning tablets (USA). Biofilm samples will be collected using sterile swabs with Amies transport medium (Boen Healthcare Co., Ltd., China). The outcome measure will be bacterial biofilm accumulation, assessed by bacteriological analysis based on bacterial colony counting, expressed as colony-forming units per milliliter (CFU/ml).

Time frame
after one month.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov
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