3D Printed Reverse Twin Block for Class III Malocclusion

NCT07710391 | Recruiting

• 1 other identifier: 1213426
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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

  T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment

Secondary Outcomes (1)

• Transverse relationship by Study model

  T0 baseline records T1 after 3 months T2 after 6 months

Other Outcomes (1)

• Oral hygiene index-children (OHI-C) will be measured

  T0 baseline record T1 after 3 months T2 after 6 months

Study Arms (2)

3D printed Reverse Twin Block appliance

EXPERIMENTAL

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

Conventional Reverse Twin Block appliance

ACTIVE COMPARATOR

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

Interventions

3D printed Reverse Twin Block appliance DEVICE

a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.

3D printed Reverse Twin Block appliance

Conventional Reverse Twin Block appliance DEVICE

a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion

Conventional Reverse Twin Block appliance

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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). -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Collage of Dentistry, University of Baghdad

Baghdad, Iraq

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Linda Basim, PhD

CONTACT

+9647812867005; landa.hadi2403@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 17, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)