NCT07792525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 13, 2026

Last Update Submit

August 25, 2026

Conditions

Growth Modification of Class II Malocclusion

Keywords

Class II malocclusionConventional twinblock3D printed twin block appliancesCephalometry

Outcome Measures

Primary Outcomes (2)

  • cephalometric analysis of angular measurements pretreatment (T0),and post-treatment (T1)dental and skeletal changes

    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

    Mean values- Mean differences- P value

    Baseline and 6 months after treatment

Study Arms (2)

Group 1

conventional group

Device: Twin Block

Group 2

3D printed group

Device: Twin Block

Interventions

Twin BlockDEVICE

Removable orthodontic appliance for growth modification

Group 1Group 2

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

prospective, blind, clinical, and radiographic trial

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Asyut, 0000, Egypt

Location

Related Links

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine ,periodontology departement

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 28, 2026

Study Start

April 1, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations

EG(1)