Class III Malocclusion
Conditions
Brief summary
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period. primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
Interventions
DEVICE3D printed Reverse Twin Block appliance
a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
DEVICEConventional Reverse Twin Block appliance
a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth. 2. Presence of permanent first molar with lower anterior teeth to retain the appliance. 3. Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm. b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2. 4. Prescence of unilateral or bilateral posterior crossbite. 5. Mild to moderate anterior crowding. 6. Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
Exclusion criteria
1. Patients with cleft lip and palate and/or craniofacial anomalies. 2. History of previous orthopedic and/or orthodontic treatment. 3. Presence of uncontrolled systemic disease or medically compromised status. 4. Uncooperative patient/parents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sagittal relation using lateral cephalometric radiograph. | T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment | By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees. 2. SNB angle in degrees. 3. ANB angle in degrees. 4. Wits appraisal in degrees. 5. SN-Pog angle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transverse relationship by Study model | T0 baseline records T1 after 3 months T2 after 6 months | This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2. 1. Intermolar width: which is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars. 2. Arch length: Arch length will be achieved by measuring the summation of right and left lines that passing through the midpoint between the distal surfaces of the deciduous second molar or the first permanent molar to the midpoint between the central incisors. |
Countries
Iraq
Contacts
CONTACTLinda Basim, PhD
Outcome results
None listed