An interventional study of 3D printed Reverse Twin Block appliance and Conventional Reverse Twin Block appliance in Class III Malocclusion, sponsored by University of Baghdad. Recruiting at 1 site in Iraq. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's planned enrollment of 30 is close to the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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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.
Exclusion Criteria:
patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin.
Device: 3D printed Reverse Twin Block appliance
patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin.
Device: Conventional 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.
a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
Changes in sagittal relation using lateral cephalometric radiograph.
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
Time frame: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
Transverse relationship by Study model
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.
Time frame: T0 baseline records T1 after 3 months T2 after 6 months
Oral hygiene index-children (OHI-C) will be measured
The six index teeth that will be included: 1. 16/55: Maxillary right permanent first molar or maxillary right primary second molar. 2. 11/51: Maxillary right permanent central incisor or maxillary right primary central incisor. 3. 26/65: Maxillary left permanent first molar or maxillary left primary second molar. 4. 36/75: Mandibular left permanent first molar or mandibular left primary second molar. 5. 31/71: Mandibular left permanent central incisor or mandibular left primary central incisor. 6. 46/85: Mandibular right permanent first molar or mandibular right primary second molar.
Time frame: T0 baseline record T1 after 3 months T2 after 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
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Malocclusion, Angle Class III →