Class II Division 1 MalocclusionNCT03635463
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency
A study testing twin block appliance and modified twin block appliance in people with Class II Division 1 Malocclusion, run by Cairo University.
Trial summary
The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency. Read more about this study
- Who is it for?
- Ages 9 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- twin block appliance and modified twin block appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2019
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Skeletal Class II relationship (ANB > 4°).
- Mandibular retrognathy (SNB < 78°).
- Overjet ≥ 5 mm.
- Minimal crowding in dental arches (≤4 mm).
- Class II molar relation.
- Growing female patients.
- Patients with CMV3 maturation stage of the cervical verbrae.
Who cannot join
- No history of orthodontic treatment either prior to or during functional Appliance therapy.
- Posterior cross bites or severe maxillary transverse deficiency.
- Severe facial asymmetry determined by clinical or radiographical examination.
- Poor oral hygiene.
- Systemic diseases that may affect the orthodontic treatment results.
- Patients past their peak growth spurt.
About this study
Official title: Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial
The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.
Read the detailed description
in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- twin block appliance, modified twin block appliance
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twin block applianceDevice
Also called mandibular functional appliance
a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)
modified twin block applianceDevice
a convetional twin block functional appliance that enhances mandibular growth in growing patients
| Study group | Role | What they receive |
|---|---|---|
| twin block appliance | Experimental | this group will receive conventional twin block appliance and followed up every month for 9 months. Receives: Device: twin block appliance |
| modified twin block appliance group | Experimental | modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months Receives: Device: modified twin block appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
enhancing mandibular skeletal growth
it will be assessed by measuring the incremental growth by quick ceph (mm)
Measured: 9 months
Secondary outcomes (3)
dentoalveolar changes
quick ceph (mm)
Measured: 9 months
Improvement of soft tissue profile
quick ceph (mm)
Measured: 9 months
Patient's compliance
table chart (no of hours/day)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies 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
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Yehia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635463
- Sponsor's protocol ID
- CEBD-CU-2018-08-05
- Status last verified
- Nov 2018
- First submitted
- 15 Aug 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03635463
- Acronym / sponsor ID
- CEBD-CU-2018-08-05
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Aug 2018 (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 evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.
Detailed description
in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| twin block appliance | Experimental | Device: twin block appliancethis group will receive conventional twin block appliance and followed up every month for 9 months. |
| modified twin block appliance group | Experimental | Device: modified twin block appliancemodified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Skeletal Class II relationship (ANB > 4°).
- Mandibular retrognathy (SNB < 78°).
- Overjet ≥ 5 mm.
- Minimal crowding in dental arches (≤4 mm).
- Class II molar relation.
Key exclusion criteria (6 listed)
- No history of orthodontic treatment either prior to or during functional Appliance therapy.
- Posterior cross bites or severe maxillary transverse deficiency.
- Severe facial asymmetry determined by clinical or radiographical examination.
- Poor oral hygiene.
- Systemic diseases that may affect the orthodontic treatment results.
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 block applianceAlso: mandibular functional appliancea functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic) | Device | twin block appliance |
| modified twin block appliancea convetional twin block functional appliance that enhances mandibular growth in growing patients | Device | modified twin block appliance group |
Primary outcome
enhancing mandibular skeletal growth
Time frame: 9 months
it will be assessed by measuring the incremental growth by quick ceph (mm)
3 secondary outcomes
dentoalveolar changes
Time frame: 9 months
Improvement of soft tissue profile
Time frame: 9 months
Patient's compliance
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: Yes
Related trials for Class II Division 1 Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
CLASS II DIVISION 1 MALOCCLUSION
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Recruiting
EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
CLASS II DIVISION 1 MALOCCLUSION
Not yet recruiting
Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
Class II Malocclusion, Class II Malocclusion, Division 1
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 twin block appliance and modified twin block appliance in people with Class II Division 1 Malocclusion, 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 7 inclusion and 6 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 3 Dec 2018. 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?
enhancing mandibular skeletal growth (time frame: 9 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 3 Dec 2018.