Mandibular RetrognathismNCT04562545
Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II
A study testing Modified Twin Block and Twin Block Appliance set to maximum bite in people with Mandibular Retrognathism and Mandibular Hypoplasia, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance Read more about this study
- Who is it for?
- Ages 9 to 13 years, women only
- Conditions the study is for
- Mandibular Retrognathism, Mandibular Hypoplasia
- What is being tested?
- Modified Twin Block and Twin Block Appliance set to maximum bite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 15 Sep 2021
- 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 13 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Growing Female Patient
- Skeletal Class II Malocclusion due to deficient mandible
- Overjet of 7 to 10 mm
- Short or normal vertical facial pattern
- No previous orthodontic nor orthopedic treatment
Who cannot join
- Syndromes or Chronic Illness
- Skeletal Class II Malocclusion due to excessive maxilla
- Vertical skeletal growth pattern
- Habits
Trial locations and contacts
1 site in 1 country.
Sahar Taher, PhD contact
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Khaled M. Hussein, B.D.S, +201558332038, Khaled.ali@dentistry.cu.edu.eg
Sahar Taher, PhD, Staher@yahoo.com
About this study
Official title: Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials
The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance
Read the detailed description
- Patients will be clinically and radio-graphically examined for eligibility
- Eligible patients will be randomly assigned to one of two groups:
- Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group
- Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group
- Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.
- Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.
- Conditions
- Mandibular Retrognathism, Mandibular Hypoplasia
- Being tested
- Modified Twin Block, Twin Block Appliance set to maximum bite
- Keywords
- Twin Block, Bite Advancement, Growth Modification
- Medical subject headings
- Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Twin BlockDevice
a modified twin block design including jack screws to facilitate incemental advancement
Twin Block Appliance set to maximum biteDevice
a traditional twin block set to maximum bite advancement at start of treatment
| Study group | Role | What they receive |
|---|---|---|
| Maximum Bite Advancement | Active comparator | Not described Receives: Device: Twin Block Appliance set to maximum bite |
| Incremental Bite Advancement | Experimental | Not described Receives: Device: Modified Twin Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses Skeletal and dentoalveolar changes in Mandible
Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in mandible.
- changes that will be assesed include ( mandibular base length / mandibular antero posterior position in relation to cranial base/ Condylar position / lower incisor inclination to mandibular plane)
Measured: 8 Months
To asses patient compliance
patient will answer a questionnaire at end of treatment
Measured: 8 months
Secondary outcomes (1)
To asses Skeletal and dentoalveolar changes in Maxilla
- Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in maxilla
- Changes that will be assesed include ( maxillary base length / maxillary base antero posterior position in relation to cranial base / incisor inclination to palatial plane)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mandibular RetrognathismStudies 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
- Model description
- Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Ali Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562545
- Sponsor's protocol ID
- CEBD-CU-2020-09-08
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share data
Publications
DeVincenzo JP, Winn MW. Orthopedic and orthodontic effects resulting from the use of a functional appliance with different amounts of protrusive activation. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):181-90. doi: 10.1016/0889-5406(89)90454-x.
PubMed 2773861Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. doi: 10.1016/j.ajodo.2004.03.024.
PubMed 15520691
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT04562545
- Acronym / sponsor ID
- CEBD-CU-2020-09-08
- Conditions
- Mandibular Retrognathism, Mandibular Hypoplasia
- Keywords
- Twin Block, Bite Advancement, Growth Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 24 Sep 2020 (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 this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance
Detailed description
- Patients will be clinically and radio-graphically examined for eligibility
- Eligible patients will be randomly assigned to one of two groups:
- Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group
- Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group
- Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.
- Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
| Arm | Type | Receives |
|---|---|---|
| Maximum Bite Advancement | Active comparator | Device: Twin Block Appliance set to maximum bite |
| Incremental Bite Advancement | Experimental | Device: Modified Twin Block |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Growing Female Patient
- Skeletal Class II Malocclusion due to deficient mandible
- Overjet of 7 to 10 mm
- Short or normal vertical facial pattern
- No previous orthodontic nor orthopedic treatment
Key exclusion criteria (4 listed)
- Syndromes or Chronic Illness
- Skeletal Class II Malocclusion due to excessive maxilla
- Vertical skeletal growth pattern
- Habits
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 Twin Blocka modified twin block design including jack screws to facilitate incemental advancement | Device | Incremental Bite Advancement |
| Twin Block Appliance set to maximum bitea traditional twin block set to maximum bite advancement at start of treatment | Device | Maximum Bite Advancement |
Primary outcome
To asses Skeletal and dentoalveolar changes in Mandible
Time frame: 8 Months
Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in mandible. - changes that will be assesed include ( mandibular base length / mandibular antero posterior position in relation to cranial base/ Condylar position / lower incisor inclination to mandibular plane)
To asses patient compliance
Time frame: 8 months
patient will answer a questionnaire at end of treatment
1 secondary outcome
To asses Skeletal and dentoalveolar changes in Maxilla
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Background: PubMed 2773861DeVincenzo JP, Winn MW. Orthopedic and orthodontic effects resulting from the use of a functional appliance with different amounts of protrusive activation. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):181-90. doi: 10.1016/0889-5406(89)90454-x.
- Background: PubMed 15520691Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. doi: 10.1016/j.ajodo.2004.03.024.
- Individual participant dataSharing planned: No. no plan to share data
Related trials for Mandibular Retrognathism
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
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Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
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Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
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Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
Class II Malocclusion, Dentofacial Deformities
Recruiting
Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Posterior Crossbite, Maxilla; Hypoplasia
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.
Sahar Taher, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Twin Block and Twin Block Appliance set to maximum bite in people with Mandibular Retrognathism and Mandibular Hypoplasia, run by Cairo 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 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 24 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled M. Hussein, B.D.S (+201558332038, Khaled.ali@dentistry.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses Skeletal and dentoalveolar changes in Mandible (time frame: 8 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?
On the ClinicalTrials.gov record for NCT04562545, which also lists 2 linked publications.
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 24 Sep 2020.