Class II Malocclusion, Division 1NCT04028661
Evaluation of 3D Printed Modified Twin Block for Correction of Skeletal Class II Malocclusion in Growing Females
A study testing 3D printed Modified Twin Block Appliance in people with Class II Malocclusion, Division 1, run by Cairo University.
Trial summary
The study is to evaluate the effect of 3D printed modified Twin Block Appliance on skeletal Class II profile correction. The null hypothesis of this research is that use of 3D Printed Twin Block is not able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison… Read more about this study
- Who is it for?
- Ages 10 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion, Division 1
- What is being tested?
- 3D printed Modified Twin Block Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Jul 2020
- 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 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Females 10-13 years of age.
- Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
- Horizontal or neutral growth pattern. (MMP ≤ 30°)
- Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
- Cervical Vertebral Maturation (CVM) stage 3.
Who cannot join
- Systemic Disease.
- Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
- Extracted or missing upper permanent tooth/teeth (except for third molars).
- Facial Asymmetry.
- Para-functional habits.
- Severe proclination or crowding that requires extractions in the lower arch.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of 3D Printed Modified Twin Block Appliance for Correction of Skeletal Class II Malocclusion in Growing Subjects: A Randomized Controlled Trial
The study is to evaluate the effect of 3D printed modified Twin Block Appliance on skeletal Class II profile correction.
The null hypothesis of this research is that use of 3D Printed Twin Block is not able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with untreated growing Class II control subjects.
Read the detailed description
I- For the treatment group:
A- Medical History Questionnaire will be filled by the patient to exclude the presence of any systemic condition.
B- Clinical Examination:
Proper examination of the oral structures including;
- Teeth will be examined for caries, fracture or missing teeth
- Gingival tissues will be examined for gingivitis, periodontitis, attachment loss, gingival recession, oral lesions and the nature of the gingival biotype.
- Thorough intraoral examination is needed to evaluate the need for referral for consultation or intervention before the initiation of treatment.
C- Diagnosis:
- The patient is checked to fulfil the inclusion criteria.
- A clinical visualized treatment outcome (VTO) will be done by asking the patient to bite in an advanced position and check the outcome of this advancement on the patient"s profile. Patients with positive results (better profiles were achieved upon advancement) are included in the study.
- Full set of records (including standardized Lateral Cephalograms) will be taken for every 8 patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
D- Clinical Procedures:
After taking upper and lower impressions, the impressions are then poured into hard stone that are then digitally scanned using 3D laboratory scanner (3Shape R500 Lab Scanner).
Designing the appliance is done on upper and lower virtual models (using 3Shape Appliance Designer). The appliance covers the upper and lower dental arches with lingual horizontal rectangular attachments to increase the retention.
Buccal triangular ramps for mandibular advancement are designed. They are positioned buccal to the upper and lower posterior segments with a lock to ensure the desired mandibular advancement.
3D printing of the appliance is then done using 3D printer (Dent2-Mogassam) with biocompatible resin material (NextDent Resin OrthoRigid).
Post curing using ultraviolet light for 30min using postcuring unit (Postcuring- Mogassam).
The appliance is then delivered to the patient and instructions are given. Follow up every 4 weeks for 8 months or edge to edge occlusion (the sooner) and then full records taken including Lateral Cephalogram.
II- For the Control group
- The subjects should be fulfilling the previously mentioned inclusion criteria and should sign the informed consent of agreement to be recruited in the study.
- According to the randomization sheet, the patients allocated to the control group will be immediately referred for the uptake of a Lateral Cephalogram which will be considered (T1) without any treatment procedures.
- A "no treatment" phase of 8 months will be carried out through which the patients will be followed up to monitor any factor that might have occurred to exclude the patient from the study.
- Another Lateral Cephalogram will be taken after 8 months (T2).
- T2 images are to be considered the initial diagnostic images for the patient. The patients will be then assessed and treatment will be provided for each patient as required.
- Conditions
- Class II Malocclusion, Division 1
- Being tested
- 3D printed 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.
3D printed Modified Twin Block ApplianceDevice
It is a functional appliance for mandibular advancement designed digitally on virtual models.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | use of 3D printed Modified Twin Block Appliance. Receives: Device: 3D printed Modified Twin Block Appliance |
| Untreated control group | No intervention | No treatment phase of 8 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Class II profile correction
A-Effective mandibular length in mm B- SNB in degrees using lateral cephalogram
Measured: 8months
Secondary outcomes (3)
Inclination of anterior teeth
A- L1/MP in degrees using lateral cephalogram B- L1-FP in mm
Measured: 8 months
Soft tissue convexity correction
Angle of convexity (N"-Sn/ N"-Pog") in degrees using lateral cephalogram
Measured: 8 months
Patient acceptance
Five point Likert scale is used to allow the individual to express how much they agree or disagree with a particular statement.
Points of Scale 5 (very satisfied) (the best) 4 (satisfied) 3 (Neutral) 2 (Dissatisfied)
1 (Very Dissatisfied) (the worst)
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 posted23 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Malocclusion, Division 1Studies 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
- The design of this randomized controlled trial is a parallel group, two arm, superiority trial with 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, : Donia Ayman Ahmed Ezzeldin ElSayed, Cairo University
- Investigators
- Donia Ezzeldin, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028661
- Sponsor's protocol ID
- 1993
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Printed Modified Twin Block Appliance for Correction of Skeletal Class II Malocclusion in Growing Subjects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04028661
- Acronym / sponsor ID
- 1993
- Conditions
- Class II Malocclusion, Division 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 23 Jul 2019 (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 study is to evaluate the effect of 3D printed modified Twin Block Appliance on skeletal Class II profile correction.
The null hypothesis of this research is that use of 3D Printed Twin Block is not able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with untreated growing Class II control subjects.
Detailed description
I- For the treatment group:
A- Medical History Questionnaire will be filled by the patient to exclude the presence of any systemic condition.
B- Clinical Examination:
Proper examination of the oral structures including;
- Teeth will be examined for caries, fracture or missing teeth
- Gingival tissues will be examined for gingivitis, periodontitis, attachment loss, gingival recession, oral lesions and the nature of the gingival biotype.
- Thorough intraoral examination is needed to evaluate the need for referral for consultation or intervention before the initiation of treatment.
C- Diagnosis:
- The patient is checked to fulfil the inclusion criteria.
- A clinical visualized treatment outcome (VTO) will be done by asking the patient to bite in an advanced position and check the outcome of this advancement on the patient"s profile. Patients with positive results (better profiles were achieved upon advancement) are included in the study.
- Full set of records (including standardized Lateral Cephalograms) will be taken for every 8 patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
D- Clinical Procedures:
After taking upper and lower impressions, the impressions are then poured into hard stone that are then digitally scanned using 3D laboratory scanner (3Shape R500 Lab Scanner).
Designing the appliance is done on upper and lower virtual models (using 3Shape Appliance Designer). The appliance covers the upper and lower dental arches with lingual horizontal rectangular attachments to increase the retention.
Buccal triangular ramps for mandibular advancement are designed. They are positioned buccal to the upper and lower posterior segments with a lock to ensure the desired mandibular advancement.
3D printing of the appliance is then done using 3D printer (Dent2-Mogassam) with biocompatible resin material (NextDent Resin OrthoRigid).
Post curing using ultraviolet light for 30min using postcuring unit (Postcuring- Mogassam).
The appliance is then delivered to the patient and instructions are given. Follow up every 4 weeks for 8 months or edge to edge occlusion (the sooner) and then full records taken including Lateral Cephalogram.
II- For the Control group
- The subjects should be fulfilling the previously mentioned inclusion criteria and should sign the informed consent of agreement to be recruited in the study.
- According to the randomization sheet, the patients allocated to the control group will be immediately referred for the uptake of a Lateral Cephalogram which will be considered (T1) without any treatment procedures.
- A "no treatment" phase of 8 months will be carried out through which the patients will be followed up to monitor any factor that might have occurred to exclude the patient from the study.
- Another Lateral Cephalogram will be taken after 8 months (T2).
- T2 images are to be considered the initial diagnostic images for the patient. The patients will be then assessed and treatment will be provided for each patient as required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design of this randomized controlled trial is a parallel group, two arm, superiority trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: 3D printed Modified Twin Block Applianceuse of 3D printed Modified Twin Block Appliance. |
| Untreated control group | No intervention | –No treatment phase of 8 months. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Females 10-13 years of age.
- Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
- Horizontal or neutral growth pattern. (MMP ≤ 30°)
- Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
- Cervical Vertebral Maturation (CVM) stage 3.
Key exclusion criteria (6 listed)
- Systemic Disease.
- Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
- Extracted or missing upper permanent tooth/teeth (except for third molars).
- Facial Asymmetry.
- Para-functional 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 |
|---|---|---|
| 3D printed Modified Twin Block ApplianceIt is a functional appliance for mandibular advancement designed digitally on virtual models. | Device | Intervention group |
Primary outcome
Skeletal Class II profile correction
Time frame: 8months
A-Effective mandibular length in mm B- SNB in degrees using lateral cephalogram
3 secondary outcomes
Inclination of anterior teeth
Time frame: 8 months
Soft tissue convexity correction
Time frame: 8 months
Patient acceptance
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 23 Jul 2019.
- Individual participant dataSharing planned: No
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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.
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The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
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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.
Donia Ezzeldin, Master principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed Modified Twin Block Appliance in people with Class II Malocclusion, Division 1, 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 5 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 23 Jul 2019. 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?
Contact Donia Ezzeldin, Master (01001200089, donia.ayman@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Class II profile correction (time frame: 8months). 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 23 Jul 2019.