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RecruitingNCT07924982Updated Nov 9, 2026

Dento-skeletal Effects of Clear Twin Block Treatment at Specific Period in Growing Patients

An interventional study of Digital twin block in CLASS II DIVISION 1 MALOCCLUSION, sponsored by University of Baghdad. Recruiting at 1 site in Iraq. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
9 Years to 12 Years
Sex
All
01

Study summary

Aim: To investigate the dento-skeletal effect of clear twin block in patients wearing the appliance at specific period.

Methods: A total of 40 patients (regardless patients sex) with an age ranged from 9 to 12 years with class Ⅱ Div1 mal-occlusion and class 2 skeletal pattern will be included in the study.

All the essential diagnostic records will be taken (for each patient) including:

  1. Pre-operative and post-operative photographs.
  2. Pre-operative and post-operative cephalometric radiographs.
  3. Pre-operative and post-operative digital models.

Another secondary records will be taken include:

  1. Pre-operative hand and wrist radiograph.
  2. Pre-operative and post-operative cone beam computed tomography (CBCT) Each patient will wear the appliance for 3 months with 16 hours per day wearing time.

All patient's parents will assign an informed consent describing the treatment protocol.

The following parameters will be assessed:

  1. Over bite, over jet, inter-canine width and inter-molar width differences on digital models.
  2. SNA, SNB, ANB, AO-BO and A-B Chang differences on lateral cephalometric radiographs.
  3. Changes on condylar head and permanent first molar root resorption on CBCT.
02

Conditions studied

  • CLASS II DIVISION 1 MALOCCLUSION
03

In context

Malocclusion, Angle Class II

124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.

This study's planned enrollment of 40 is above the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.

Browse Malocclusion, Angle Class II studies →

Lead sponsor

University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.

Browse University of Baghdad studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age ranged from 9 to 12 years
  • class Ⅱ Div1 mal-occlusion and class 2 skeletal pattern

Exclusion criteria

Exclusion Criteria:

  • Adults (passing the puberty)
  • Refuse to participate in the study
  • Uncooperative patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Treatment arm with digital twin block appliance

    Device: Digital twin block

Interventions

  • DeviceDigital twin block

    Digital twin block used to treat class II skeletal malocclsuion

06

What researchers measure

Primary outcomes

  1. Arch width

    Maxillary and mandibular inter-molar and premolar widths

    Time frame: 3 months

  2. CBCT measurements

    Linear measurements in millimeters

    Time frame: 3 months

  3. CBCT measurements

    Angular measurements

    Time frame: 3 months

  4. CBCT measurements

    Volumetric measurements in cubic millimeters

    Time frame: 3 months

Secondary outcomes

  1. Cephalometric radiographs

    Cephalometric angular measurements

    Time frame: 3 months

  2. Cephalometric radiographs

    Cephalometric linear measurements

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — To protect the patinets' privacy

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924982
Lead sponsor
University of Baghdad
Responsible party
Mohammed Nahidh (Professor, University of Baghdad) — Principal investigator
First posted
Nov 9, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Jan 25, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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