Skeletal Class II MalocclusionNCT07270653
Assesment of Tempromandibular Joint ( TMJ ) Changes After Treatment of Skeletal Class II Cases by Twinblock vs Monoblock Appliances
A study testing twin block and Mono block in people with Skeletal Class II Malocclusion, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Assesment of TMJ changes after treatment of skeletal classII growing patients by Twinblock vs Mono block applinces Read more about this study
- Who is it for?
- Ages 9 to 12 years, women only
- Conditions the study is for
- Skeletal Class II Malocclusion
- What is being tested?
- twin block and Mono block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 11 Nov 2025
- Phase
- Interventional
- 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 12 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- skeletal class II malocclusion
- Defecient mandible
- ANB >4
- Growing female patients
- Age from 9-12 years
Who cannot join
- TMJ disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Tempromandibular Joint Changes After Treatment of Skeletal Class II Growing Patients by Twin Block Versus Monoblock
Assesment of TMJ changes after treatment of skeletal classII growing patients by Twinblock vs Mono block applinces
Read the detailed description
Group (A): patients were treated by Twin block appliance Group (B): patients were treated by Mono block appliance
- Conditions
- Skeletal Class II Malocclusion
- Being tested
- twin block, Mono block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twin blockDevice
Treatment of Skeletal class II by mandibular advancement using twinblock appliances ( removable myofunctional appliance)
Mono blockDevice
Treatment of Skeletal class II by mandibular advancement using Mono block appliances ( removable myofunctional appliance)
| Study group | Role | What they receive |
|---|---|---|
| Treatment of skeletal class II by mandibular advancement using Twin block appliance | Experimental | Twinblock group Receives: Device: twin block |
| treatment of skeletal class II by mandibular advancement using Mono block appliance | Experimental | Monoblock group Receives: Device: Mono block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Tempromandibular changes including, condylar volume ( in cubic millimeters), length ( in millimeters) , height ( in millimeters) and position( in millimeters)
full skull CBCT
Measured: 8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start15 Aug 2023
- Primary completion30 Sep 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class II MalocclusionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatema Mohamad, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270653
- Sponsor's protocol ID
- ORTO-108-2-G
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tempromandibular Joint Changes After Treatment of Skeletal Class II Growing Patients by Twin Block Versus Monoblock
- ClinicalTrials.gov ID
- NCT07270653
- Acronym / sponsor ID
- ORTO-108-2-G
- Conditions
- Skeletal Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 8 Dec 2025 (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.
Assesment of TMJ changes after treatment of skeletal classII growing patients by Twinblock vs Mono block applinces
Detailed description
Group (A): patients were treated by Twin block appliance Group (B): patients were treated by Mono block appliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of skeletal class II by mandibular advancement using Twin block appliance | Experimental | Device: twin blockTwinblock group |
| treatment of skeletal class II by mandibular advancement using Mono block appliance | Experimental | Device: Mono blockMonoblock group |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- skeletal class II malocclusion
- Defecient mandible
- ANB >4
- Growing female patients
- Age from 9-12 years
Key exclusion criteria (1 listed)
- TMJ disease
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 blockTreatment of Skeletal class II by mandibular advancement using twinblock appliances ( removable myofunctional appliance) | Device | Treatment of skeletal class II by mandibular advancement using Twin block appliance |
| Mono blockTreatment of Skeletal class II by mandibular advancement using Mono block appliances ( removable myofunctional appliance) | Device | treatment of skeletal class II by mandibular advancement using Mono block appliance |
Primary outcome
Assessment of Tempromandibular changes including, condylar volume ( in cubic millimeters), length ( in millimeters) , height ( in millimeters) and position( in millimeters)
Time frame: 8-12 months
full skull CBCT
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 8 Dec 2025.
- Comparison of Skeletal Changes in the Temporomandibular Joint between the Twin Block Appliance and Fixed Functional Appliance: A Longitudinal Follow-up StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 study testing twin block and Mono block in people with Skeletal Class II Malocclusion, run by Faculty of Dental Medicine for Girls 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 1 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 8 Dec 2025. 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?
Assessment of Tempromandibular changes including, condylar volume ( in cubic millimeters), length ( in millimeters) , height ( in millimeters) and position( in millimeters) (time frame: 8-12 months). 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 8 Dec 2025.