Skeletal MalocclusionNCT06631235
Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II
A study testing orthopedic appliance and aesthetic orthopedic appliance in people with Skeletal Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients) Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Skeletal Malocclusion
- What is being tested?
- orthopedic appliance and aesthetic orthopedic appliance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.
- Mandibular deficiency (SNB angle less than 77°).
- Growing patients.
- No prior orthodontic intervention.
- The vertical skeletal classification shows a horizontal or neutral growth pattern.
- Overjet ≥ 8mm.
Who cannot join
- Developmental abnormalities with atypical or irregular patterns of growth and maturation.
- Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, 35516
Rana Ka Abozeid, Doctor, 01009389116, ranaabuzaid52@gmail.com
About this study
Official title: Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II: Randomized Controlled Study
The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)
Read the detailed description
The sample will be randomly divided into 2 equal groups according to the appliance will be used:
Group 1: Aesthetic Functional appliance Group 2: Twin block
Methods:
*Radiographs (CBCT) will be taken before starting the treatment (T1) and after obtaining Class I occlusion and normal overjet (T2) by sequential appliances.
appliances.
- Lateral cephalograms -extracted from CBCT- will be used to evaluate the effect of the two appliances.
- CBCT will be used to evaluate root resorption and bony changes in the condyle .
- Conditions
- Skeletal Malocclusion
- Being tested
- orthopedic appliance, aesthetic orthopedic appliance
- Keywords
- classII, mandibular advancement, twin block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthopedic applianceOther
appliances are used to correct skeletal class II due to mandibular deficiency
aesthetic orthopedic applianceOther
aesthetic appliances are used to correct skeletal class II due to mandibular deficiency
| Study group | Role | What they receive |
|---|---|---|
| twin block group | Other | patient treated with twin block appliance Receives: Other: orthopedic appliance |
| aesthetic functional group | Experimental | patient treated with aesthetic functional appliance Receives: Other: aesthetic orthopedic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal effects
cephalometric linear and angular measurements
Measured: one year
dental effects
cephalometric linear and angular measurements
Measured: one year
soft tissue effects
cephalometric linear and angular measurements
Measured: one year
Secondary outcomes (1)
root resorption
root resorption measured from CBCT
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- rana ka Abuzaid, orthodontist, Principal investigator, Egyption orthodontic socity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631235
- Sponsor's protocol ID
- A04070240R
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: skeletal and dental results
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06631235
- Acronym / sponsor ID
- A04070240R
- Conditions
- Skeletal Malocclusion
- Keywords
- classII, mandibular advancement, twin block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Oct 2024 (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 goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)
Detailed description
The sample will be randomly divided into 2 equal groups according to the appliance will be used:
Group 1: Aesthetic Functional appliance Group 2: Twin block
Methods:
*Radiographs (CBCT) will be taken before starting the treatment (T1) and after obtaining Class I occlusion and normal overjet (T2) by sequential appliances.
appliances.
- Lateral cephalograms -extracted from CBCT- will be used to evaluate the effect of the two appliances.
- CBCT will be used to evaluate root resorption and bony changes in the condyle .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| twin block group | Other | Other: orthopedic appliancepatient treated with twin block appliance |
| aesthetic functional group | Experimental | Other: aesthetic orthopedic appliancepatient treated with aesthetic functional appliance |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.
- Mandibular deficiency (SNB angle less than 77°).
- Growing patients.
- No prior orthodontic intervention.
- The vertical skeletal classification shows a horizontal or neutral growth pattern.
Key exclusion criteria (2 listed)
- Developmental abnormalities with atypical or irregular patterns of growth and maturation.
- Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.
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 |
|---|---|---|
| orthopedic applianceappliances are used to correct skeletal class II due to mandibular deficiency | Other | twin block group |
| aesthetic orthopedic applianceaesthetic appliances are used to correct skeletal class II due to mandibular deficiency | Other | aesthetic functional group |
Primary outcome
skeletal effects
Time frame: one year
cephalometric linear and angular measurements
dental effects
Time frame: one year
cephalometric linear and angular measurements
soft tissue effects
Time frame: one year
cephalometric linear and angular measurements
1 secondary outcome
root resorption
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: Yes. skeletal and dental results
Related trials for Skeletal Malocclusion
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
Active, not recruiting
Modified Versus Clear Twin Block for Skeletal Class II Malocclusion
Skeletal Class II Malocclusion
Enrolling by invitation
Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion
Skeletal Class III Malocclusion
RecruitingObservational study
Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
Dentofacial Abnormalities, Dentofacial Deformities
Recruiting
"Sliding Jigs vs Retraction Hooks for Maxillary Dentition Distalization Using IZC Miniscrews"
Skeletal Class II Malocclusion
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.
rana ka Abuzaid, orthodontist principal investigator
Egyption orthodontic socity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthopedic appliance and aesthetic orthopedic appliance in people with Skeletal Malocclusion, run by Mansoura 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rana ka Abuzaid, orthodontist (1009389116, ranaabuzaid52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal effects (time frame: one year). The study lists 3 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 21 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.