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

Dento-skeletal Effects of Clear Twin Block Treatment at Specific Period in Growing Patients: A CBCT Based Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: CLASS II DIVISION 1 MALOCCLUSION
• Intervention / Treatment: Device: Digital twin block

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad Governorate
    • Baghdad, Baghdad Governorate, Iraq, 10001
      • Recruiting
      • Samer Salim Othman
      • Contact: Samer Salim Othman, Ph.D.; Phone Number: 00964 7805557766; Email: samerortho@ibnsina.edu.iq
      • Contact: Mohammed Nahidh, Ph.D.; Phone Number: 00964 7702551616; Email: m_nahidh79@codental.uobaghdad.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Treatment arm with digital twin block appliance	Device: Digital twin block; Digital twin block used to treat class II skeletal malocclsuion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arch width	Maxillary and mandibular inter-molar and premolar widths	3 months
CBCT measurements	Linear measurements in millimeters	3 months
CBCT measurements	Angular measurements	3 months
CBCT measurements	Volumetric measurements in cubic millimeters	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cephalometric radiographs	Cephalometric angular measurements	3 months
Cephalometric radiographs	Cephalometric linear measurements	3 months

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: October 20, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II
• Other Study ID Numbers: ISU.26.1.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

To protect the patinets' privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No