Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorMansoura University
About this trial
This randomized controlled clinical trial aims to evaluate the effect of posterior disarticulatory resin bite turbos on the rate of maxillary expansion using a HYRAX expander in early adolescent patients. Participants will be randomly assigned to receive either maxillary expansion with posterior resin bite turbos or conventional expansion without bite turbos. The study will assess and compare the rate and effectiveness of maxillary expansion between the two groups during the treatment period. Clinical measurements will be recorded to evaluate skeletal and dental changes associated with the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 10-14 years.
Bilateral posterior cross bite.
Functional lateral cross bite.
Good general and oral health.
Disqualifiers
Patients with cleft lip and palate.
Severe facial asymmetry.
Anterior open bite.
Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos
DeviceDescription: Arm 1: Participants in this group receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on the posterior teeth to disclude the occlusion, aiming to reduce occlusal interference and potentially enhance skeletal response during maxillary expansion. The HYRAX appliance is activated according to a standardized expansion protocol.
Intervention 2 (Control): HYRAX expander alone
DeviceParticipants in this group receive a HYRAX rapid maxillary expansion appliance alone without the use of posterior bite turbos. The appliance is activated following the same standardized expansion protocol as the intervention group.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: group 1: HYRAX with posterior bite turbosExperimental treatment 1 intervention
Group B: Group 2 : Expansion without posterior bite turbosActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models
Dental landmarks and measurements on models : d3 :Canine tip. d4: Central fissure of first premolar. d6 :Central fissure of first permanent molar. d\_3( inter canine width): Distance between left and right d3. d\_4 (inter first premolar width) : Distance between left and right d4. d\_6(inter first molar width): Distance between left and right d6.
Time frame
Baseline and weekly during the active phase of expansion and after 3 months of retentionSecondary outcomes
1
-The effect of the posterior disarticulation on alveolar bone changes by CBCT .
Skeletal transverse, vertical, nasal width changes and axial inclination of posterior teeth will be evaluated .
Time frame
baseline and after three months of retention after complete active expansion2
pain felt by the patient after activating the expansion screw
ain will be assessed using the Visual Analogue Scale (VAS), a 100 mm line with "no pain" at the left end and "the worst unbearable pain" at the right, which corresponds to a pain score between 0 and 10. All participants will be asked to place a vertical mark indicating the level of pain on the VAS 4 h after each activation for the first two weeks in diary sheet containing the actual size of a 100mm of VAS. 25
Time frame
first two weeks in active phase of expansionSponsors and contacts
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Source ClinicalTrials.gov