NCT07795138

Brief Summary

: 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2024

Typical duration for phase_1

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

January 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 24, 2026

Last Update Submit

August 31, 2026

Conditions

Class II Malocclusion

Keywords

Class II malocclusionfunctional treatmentgrowth modificationTwin blockLower lipSoft tissue changes

Outcome Measures

Primary Outcomes (2)

  • Lateral cephalometric radiographs

    angular degree

    Baseline and 6 months after treatment

  • Lateral cephalometric radiographs

    linear measurements by mm

    Baseline and 6 months after treatment

Study Arms (2)

Group 1

EXPERIMENTAL

ten Patients treated using a conventional twin block appliance

Device: Twin Block

Group 2

ACTIVE COMPARATOR

ten Patients treated using a 3-D printed twin block appliance

Device: Twin Block

Interventions

Twin BlockDEVICE

Functional Device

Group 1Group 2

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Young, growing age
  • Class II malocclusion
  • Increased overjet.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine,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
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine ,periodontology departement

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 31, 2026

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations

EG(1)