Distalization by Miniscrews, Tooth Movement Techniques
Conditions
Keywords
Distalization, tooth movement, 3D printing
Brief summary
A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding.
Detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional miniscrew-supported distal jet appliance will be used while for group two, new 3D printed miniscrew-supported molar distalizers is going to be utilized. Lateral cephalometric x-ray and digital models of upper arch will be taken before starting the treatment (T0) and at the end of molar distalization (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.
Interventions
DEVICEGroup 1 conventional
Conventional miniscrew-supported distal jet appliance
DEVICEGroup 2 3D printed
New 3D printed miniscrew-supported molar distalizers
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study will be a single blinded because both the patients and the investigator will be aware of the allocation during treatment, but the cephalograms and digital models will be scored and coded by an independent person, i.e. pre-and post-treatment cephalograms and digital models will be analyzed after replacing the patients' names with codes, and the examiner conducting the measurement analysis will be unaware of the group to which the patient has been allocated.
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Class II molar relationships bilaterally, with fully erupted 2nd molar. 2. No or minor crowding on the mandible to \[reserve Class I posterior occlusion after treatment. 3. Good oral health free from caries and periodontal problems at the start of treatment. \-
Exclusion criteria
1. Previous history of orthopedic and/or orthodontic treatment. 2. Patients with cleft lip and palate and/or craniofacial syndrome 3. Patients with bad oral habit. 4. Active periodontal disease. 5. Sever rotation of maxillary molars. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of molar Distalization | 6 months | • The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient discomfort | 10 days | • Patient's pain and discomfort using visual analogue scale (VAS). The minimum score is zero and the maximum score is 10. |
| Molar distalization | 6 months | The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements. - The efficiency of molar distalization in terms of the amount of molar distalization, - degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements |
Countries
Iraq
Contacts
Primary ContactMushriq Abid Fawzi Professor, PhD
Outcome results
None listed