Class I Malocclusion, Crowded Teeth, Rotation, Spacing of Anterior Teeth
Conditions
Keywords
direct printed graphy... thermoform
Brief summary
The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligners.
Detailed description
the patients will be randomly assigned to one of two study groups which either direct printed or thermoformed clear aligner. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.Teeth positions would be planned according to esthetic and functional principles, starting with the 3D T0 digital model and aligning and leveling dental arches following orthodontic aligner biomechanical principles. Each aligner had a planned movement speed of 0.2 mm linear displacement, 2° long-axis rotation, and a vestibulo-lingual inclination of 2.5°.
Interventions
DEVICEDirect-printed aligner (Graphy)
intraoral scanner would be used to scan patient teeth then aligner fabrication by direct printing then the patient will be treated with direct-printed aligners(graphy) until dental levelling alignment; space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.
DEVICEThermoformed aligner
An intraoral scanner would be used to scan patient teeth then aligner fabrication by thermoforming then the Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients with mild to moderate malocclusion that can be treated by less than 40 steps of aligner treatment, including those with dental rotation of \< 30°, diastema or crowding of \< 8 mm. * Patients aged ≥ 16 years with fully erupted permanent teeth (regardless of the third molar). * No supernumerary teeth, no enamel malformation. * No tooth shape anomalies
Exclusion criteria
* Systemic pathologies such as uncontrolled diabetes or heart diseases * active or past periodontal disease * previous orthodontic treatment * temporomandibular joint disorders * ongoing pharmacological treatment could influence orthodontic treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| predictability of tooth movement | 12 months | The primary outcome will be calculated as the percentage difference between the final and initial positions for each individual tooth movement assessed and will be expressed as a continuous numerical variable representing tooth movement predictability (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| predictability within different types | 12 months | 1\. The secondary outcome will be assessed by comparing the predictability within different types of tooth movement of the same group. |
| Colour change of clear aligners | 12 months | UV-Visible spectrophotometer for samples from both groups before and after intraoral aging. |
| Degree of Conversion | 12 months | Assessment of the Degree of Conversion of direct printed Tera Harz TA-28 resin using Fourier-transform infrared (FTIR) spectroscopy for the liquid resin before curing and for samples after curing and post-processing. |
| shape memory effect | 12 months | Assessment of the shape memory effect of direct printed Tera Harz TA-28 aligners, the bending test would be used to investigate and directly visualize the shape recovery property. |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORhussin anwar
University of Baghdad
Outcome results
None listed