Growth ModificationNCT06589206
Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance
A study testing modified design of twin block in people with Growth Modification, run by Cairo University.
Trial summary
The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed. Read more about this study
- Who is it for?
- Ages 10 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Modification
- What is being tested?
- modified design of twin block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Oct 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 10 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- skeletal class II deficient mandible
- Class II molar and canine relation
- male growing patients CVM 2,3 age range 10-14
- normal vertical growth pattern
- ANB > 4
- mild to moderate crowding
Who cannot join
- Previous orthodontic treatment.
- Craniofacial syndrome.
- Periodontal disease.
- Extracted first permanent molars.
About this study
Official title: Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial
The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.
Read the detailed description
Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.
- Conditions
- Growth Modification
- Being tested
- modified design of twin block
- Keywords
- twin block, esthetic twin block, clear twin block, Deficient mandible, Skeletal Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified design of twin blockOther
Vacuum formed twin block appliance with sagittal blocks
| Study group | Role | What they receive |
|---|---|---|
| conventional twin block | Active comparator | Growing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with the conventional design of twin block previously introduced by Clark. Receives: Other: modified design of twin block |
| Vacuum formed twin block appliance with sagittal blocks | Experimental | Growing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with a modified design of twin block formed of vacuum sheets with sagittal blocks. Receives: Other: modified design of twin block |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal changes
changes in SNA, SNB, and ANB angles will be measured before and after treatment
Measured: 9 months
Dental changes
changes in maxillary and mandibular incisors position and inclination will be assessed before and after treatment
Measured: 9 months
Secondary outcomes (4)
soft tissue changes
changes in soft tissue A, B, Pog points will be assessed before and after treatment
Measured: 9 months
JMJ changes
changes in the TMJ morphologic structure will be assessed before and after treatment
Measured: 9 months
Upper airway size
changes in the Upper airway size will be assessed before and after treatment
Measured: 9 months
patient satisfaction
patients acceptance of the appliance will be assessed by a questionnaire administered in one to one interview.
Measured: after one and nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth ModificationStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Saeed Mohamed Abdel qader, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589206
- Sponsor's protocol ID
- 3444
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06589206
- Acronym / sponsor ID
- 3444
- Conditions
- Growth Modification
- Keywords
- twin block, esthetic twin block, clear twin block, Deficient mandible, Skeletal Class II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 19 Sep 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 aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.
Detailed description
Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional twin block | Active comparator | Other: modified design of twin blockGrowing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with the conventional design of twin block previously introduced by Clark. |
| Vacuum formed twin block appliance with sagittal blocks | Experimental | Other: modified design of twin blockGrowing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with a modified design of twin block formed of vacuum sheets with sagittal blocks. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- skeletal class II deficient mandible
- Class II molar and canine relation
- male growing patients CVM 2,3 age range 10-14
- normal vertical growth pattern
- ANB > 4
Key exclusion criteria (4 listed)
- Previous orthodontic treatment.
- Craniofacial syndrome.
- Periodontal disease.
- Extracted first permanent molars.
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 |
|---|---|---|
| modified design of twin blockVacuum formed twin block appliance with sagittal blocks | Other | Vacuum formed twin block appliance with sagittal blocks, conventional twin block |
Primary outcome
skeletal changes
Time frame: 9 months
changes in SNA, SNB, and ANB angles will be measured before and after treatment
Dental changes
Time frame: 9 months
changes in maxillary and mandibular incisors position and inclination will be assessed before and after treatment
4 secondary outcomes
soft tissue changes
Time frame: 9 months
JMJ changes
Time frame: 9 months
Upper airway size
Time frame: 9 months
patient satisfaction
Time frame: after one and nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing modified design of twin block in people with Growth Modification, run by Cairo University.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
skeletal changes (time frame: 9 months). 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 19 Sep 2024.