Class II MalocclusionRCTNCT07792525
Conventional Versus 3D Printed Twin Block Appliances in Growth Modification of Class II Malocclusion
An observational study of Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Twin Block
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: prospective, blind, clinical, and radiographic trial
Who may be able to join
- 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. .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Class II Malocclusion
- Being tested
- Twin Block
- Keywords
- Class II malocclusion, Conventional twinblock, 3D printed twin block appliances, Cephalometry
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin BlockDevice
Removable orthodontic appliance for growth modification
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | conventional group Receives: Device: Twin Block | |
| Group 2 | 3D printed group Receives: Device: Twin Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
cephalometric analysis of angular measurements pretreatment (T0),and post-treatment (T1)dental and skeletal changes
Mean values- Mean difference- p value
Measured: 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
Measured: Baseline and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Apr 2024
- Primary completion1 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Hussein Rafat Kotb, Sphinx university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792525
- Sponsor's protocol ID
- AUAREC20240003-7
- Acronym
- RCT
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus 3D Printed Twin Block Appliances in Growth Modification of Class II Malocclusion (Comparative Clinical Study) A Thesis
- ClinicalTrials.gov ID
- NCT07792525
- Acronym / sponsor ID
- RCT / AUAREC20240003-7
- Conditions
- Class II Malocclusion
- Keywords
- Class II malocclusion, Conventional twinblock, 3D printed twin block appliances, Cephalometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Twin Blockconventional group |
| Group 2 | – | Device: Twin Block3D printed group |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- prospective, blind, clinical, and radiographic trial
Key inclusion criteria (5 listed)
- 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. .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twin BlockRemovable orthodontic appliance for growth modification | Device | Group 1, Group 2 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- orcidLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cephalometric analysis of angular measurements pretreatment (T0),and post-treatment (T1)dental and skeletal changes (time frame: Baseline and 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.