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NCT Number: NCT07710391

3D Printed Reverse Twin Block for Class III Malocclusion

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.

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Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Collage of Dentistry, University of Baghdad

Baghdad, Iraq

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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

    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 outcomes

  1. Transverse relationship by Study model

    Time frame: 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.

    • Intermolar width: which is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars.
    • 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.

Other outcomes

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

    Time frame: T0 baseline record T1 after 3 months T2 after 6 months

    The six index teeth that will be included:

    • 16/55: Maxillary right permanent first molar or maxillary right primary second molar.
    • 11/51: Maxillary right permanent central incisor or maxillary right primary central incisor.
    • 26/65: Maxillary left permanent first molar or maxillary left primary second molar.
    • 36/75: Mandibular left permanent first molar or mandibular left primary second molar.
    • 31/71: Mandibular left permanent central incisor or mandibular left primary central incisor.
    • 46/85: Mandibular right permanent first molar or mandibular right primary second molar.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Basim, PhD

CONTACT

[email protected]

+9647812867005

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial

Acronym: 3DRTB

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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