Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

Study Overview
=================
Brief Summary
-----------------
The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

Detailed Description
-----------------
Methodology: Basic orthodontic record will be taken. impression with bands on upper first molars will be taken. Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany). CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches. Delivery, check the retention and fitness of the appliance. Cementation of the appliance using band cement(compomer). Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted. Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema. Closure of the device, and leave the appliance in-situ for five months as a retention. Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated

Official Title
-----------------
Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial.

Conditions
-----------------
Transverse Maxillary Deficiency

Intervention / Treatment
-----------------
* Device: Hybrid Hyrax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral or bilateral Dental posterior cross-bite Skeletal Maxillary constriction Male and female patients. Chronological age (18-30 years). Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification Good oral hygiene. No craniofacial anomalies or syndromes Exclusion Criteria: Scissor-bite Orthodontically-treated functional cross bite due to premature occlusal contact patients with a syndrome cleft patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Hyrax<br>Device: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax Other Names: • MARPE(miniscrews-assisted rapid palatal expander) | Device: Hybrid Hyrax<br>* these patents will be treated using Two mini-screws supported hybrid hyrax<br>* Other names: MARPE(miniscrews-assisted rapid palatal expander);|
| No Intervention: Untreated control group<br>Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion | To compare the amount of skeletal expansion using linear and angular measurements and the expansion pattern of mid-palatal suture extracted from cone beam computed tomography pre and post expansion | the outcome will be assessed five months post-expansion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dento-alaveolar expansion | To compare the amount of dento-alveolar expansion using linear and angular measurements extracted from cone beam computed tomography pre and post-expansion | the outcome will be assessed five months post-expansion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maxillary expansion