3D Printed Reverse Twin Block for Class III Malocclusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D printed Reverse Twin Block appliance, Conventional Reverse Twin Block appliance.
- Who it may be relevant to
- Registry conditions: Class III Malocclusion. Basic parameters: 8 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial
Overview
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
- Device 3D 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. - Device Conventional 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
Primary outcome measures
- Changes in sagittal relation using lateral cephalometric radiograph. [Time frame: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment]
Secondary outcome measures (1)
- Transverse relationship by Study model [Time frame: T0 baseline records T1 after 3 months T2 after 6 months]
Eligibility criteria
Inclusion criteria
- 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.
- Presence of permanent first molar with lower anterior teeth to retain the appliance.
- 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.
- Prescence of unilateral or bilateral posterior crossbite.
- Mild to moderate anterior crowding.
- Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
Exclusion criteria
- Patients with cleft lip and palate and/or craniofacial anomalies.
- History of previous orthopedic and/or orthodontic treatment.
- Presence of uncontrolled systemic disease or medically compromised status.
- Uncooperative patient/parents.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Collage of Dentistry, University of Baghdad — Baghdad
Identifiers
NCT: NCT07710391 · 1213426