Conventional Versus 3D Printed Twin Block Appliances in Growth Modification of Class II Malocclusion (RCT)

August 27, 2026 updated by: Shimaa Hussein Rafat Kotb, Al-Azhar University

Conventional Versus 3D Printed Twin Block Appliances in Growth Modification of Class II Malocclusion (Comparative Clinical Study) A Thesis

The present study was conducted to evaluate the outcomes of conventionl versus 3D printed twin block appliances in growth modification of class II malocclusion (comparative clinical study) in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to evaluate the effects of treatment by conventional and 3D printed Twin Block for growth modification of class II malocclusion. This study was carried out upon twenty young growing age patients with class II malocclusion retruded mandible. The patients were selected from patients seeking orthodontic treatment in out-patient clinic, orthodontic department, Al-Azhar University, Asyut, Egypt. They were randomly divided into two groups: each consisted of 10 patients as follows: The first group consisted of 10 patients, who received conventional twin block removable functional appliance therapy; the second group consisted of 10 patients, who received 3D printed twin block removable functional appliance therapy.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt, 0000
        • Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

prospective, blind, clinical, and radiographic trial

Description

Inclusion Criteria:

  1. Young, growing age range from 9 to 16 years old.
  2. Class II malocclusion with retruded mandible.
  3. Increased overjet.
  4. Horizontal to average growth pattern determined by cephalometric radiograph.
  5. Positive pretreatment VTO detected by clinical examination. .

Exclusion Criteria:

  1. Severe proclination of anterior teeth.
  2. Severe crowding of anterior teeth.
  3. Systemic disease that affects bone and general growth
  4. History of previous orthodontic treatment.
  5. Patient refuses a removable appliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
conventional group
Device: Twin Block
Removable orthodontic appliance for growth modification
Group 2
3D printed group
Device: Twin Block
Removable orthodontic appliance for growth modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cephalometric analysis of angular measurements pretreatment (T0),and post-treatment (T1)dental and skeletal changes
Time Frame: Baseline and 6 months after treatment
Mean values- Mean difference- p value
Baseline and 6 months after treatment
cephalometric analysis of Linear measurements pretreatment (T0),and post-treatment (T1) dental and skeletal changes
Time Frame: Baseline and 6 months after treatment
Mean values- Mean differences- P value
Baseline and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

August 13, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUAREC20240003-7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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