Class II MalocclusionPhase 1Clinic RadiogrNCT07795138
Comparative Effect of Conventional and 3D-printed Twin Block Appliances on Soft Tissue Changes
A Phase 1 study testing Twin Block in people with Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial 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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Mar 2026
- Phase
- Phase 1
- 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
Who may be able to join
- Young, growing age
- Class II malocclusion
- Increased overjet.
Who cannot join
- Severe proclination of anterior teeth.
- Severe crowding of anterior teeth.
- Systemic disease affecting bone and growth.
Trial locations and contacts
1 site in 1 country.
About this study
: 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.
Read the detailed description
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.
- Conditions
- Class II Malocclusion
- Being tested
- Twin Block
- Keywords
- Class II malocclusion, functional treatment, growth modification, Twin block, Lower lip, Soft tissue changes
- 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
Functional Device
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ten Patients treated using a conventional twin block appliance Receives: Device: Twin Block |
| Group 2 | Active comparator | ten Patients treated using a 3-D printed twin block appliance Receives: Device: Twin Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral cephalometric radiographs
angular degree
Measured: Baseline and 6 months after treatment
Lateral cephalometric radiographs
linear measurements by mm
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 posted31 Aug 2026
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT07795138
- Sponsor's protocol ID
- AUARC20240003-7
- Acronym
- Clinic Radiogr
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Conventional and 3D-printed Twin Block Appliances on Soft Tissue Changes
- ClinicalTrials.gov ID
- NCT07795138
- Acronym / sponsor ID
- Clinic Radiogr / AUARC20240003-7
- Conditions
- Class II Malocclusion
- Keywords
- Class II malocclusion, functional treatment, growth modification, Twin block, Lower lip, Soft tissue changes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 31 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.
: 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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Twin Blockten Patients treated using a conventional twin block appliance |
| Group 2 | Active comparator | Device: Twin Blockten Patients treated using a 3-D printed twin block appliance |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Young, growing age
- Class II malocclusion
- Increased overjet.
Key exclusion criteria (3 listed)
- Severe proclination of anterior teeth.
- Severe crowding of anterior teeth.
- Systemic disease affecting bone and growth.
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 BlockFunctional Device | Device | Group 1, Group 2 |
Primary outcome
Lateral cephalometric radiographs
Time frame: Baseline and 6 months after treatment
angular degree
Lateral cephalometric radiographs
Time frame: Baseline and 6 months after treatment
linear measurements by mm
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 1 Sep 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?
A Phase 1 study testing Twin Block in people with 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 3 inclusion and 3 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 1 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lateral cephalometric radiographs (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 1 Sep 2026.