Skip to main content
OpenTrials
Completed

NCT Number: NCT07795138

Comparative Effect of Conventional and 3D-printed Twin Block Appliances on Soft Tissue Changes

: To evaluate the effectiveness of functional device treatment using both 3D-printed and conventional Twin Block appliances on soft tissue changes during growth modification in Class II malocclusion.

Completed

Looking for future studies?

Notify Me

Key information

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dental Medicine,Al-Azhar University

Asyut, 0000, Egypt

About this study

Background: Enhancing facial aesthetics is the main target of orthodontic treatment, as appearance greatly influences a person's social confidence and self-esteem. Skeletal Class II malocclusion is quite common, and the pubertal growth spurt is the perfect time for functional treatment to promote mandibular advancement. The Twin-Block, one of the most widely used functional appliances, is a popular choice for achieving this goal..

Patients and methods: Twenty patients divided into two groups with mixed or early permanent dentition were enrolled. Lateral cephalometric radiographs were taken at the start (T0; before treatment) and end (T1; at the end of the active phase) using the same machine. Those of each patient treated with a conventional Twin Block appliance for class II malocclusion were compared to those of patients treated with a 3D-printed Twin Block appliance for a 6-month follow-up period. Both groups were evaluated for soft tissue changes using various angular and linear geometric measurements, and differences between pre- and post-treatment were analyzed with a paired t-test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

1- Young, growing age from 9 to 16 years. 2. Class II malocclusion with retruded mandible. 3. Increased overjet.

Exclusion criteria

  • Severe proclination of anterior teeth. 2. Severe crowding of anterior teeth. 3. Systemic disease affecting bone and general growth.

-

Treatment and study plan

Twin Block

Device

Functional Device

Primary outcomes

  1. Lateral cephalometric radiographs

    Time frame: Baseline and 6 months after treatment

    angular degree

  2. Lateral cephalometric radiographs

    Time frame: Baseline and 6 months after treatment

    linear measurements by mm

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Acronym: Clinic Radiogr

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 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.

Published trials that share one or more normalized conditions with this study.