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Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.
Damon Ultima System was introduced and claimed to be the first true full expression orthodontic system designed for faster and more precise finishing. The brackets were completely reengineered to virtually eliminate play for precise control of rotation, angulation and torque. Moreover, the system used specially designed archwires regarding wire dimensions and shape to fulfill the manufacturers claim.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Damon Ultima brackets | Experimental | Damon Ultima brackets |
|
| conventional Roth appliance | Experimental | conventional Roth appliance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damon Ultima bracket | Device | It is metal twin bracket with their recommended arch wire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusal outcomes assessment | 1. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores < 0.5 = 0. 0.5 to 1 mm =1. > 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete. SO: the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome | 1 year |
| Little Irregularity index: | This technique involves measuring the linear distance from anatomic contact point to the adjacent anatomic contact point of the mandibular anterior teeth , used to assess the changes in dental alignment throughout the study. initial irregularity index is (3 mm to 7mm) = worse out come and the final irregularity index is zero mm= best out come | 6 months |
| Arch parameter measurement: | Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch | 1 year |
| Root alingment | Root movement in 3 plane of space will be evaluated at the end of the alignment phase after insertion of stainless steel wire which may will Tacke about 6 months and at the end of the treatment after about 6 months using CBCT. The inclination of upper and lower teeth will be assessed | 1 year |
| Root resorption | Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience and satisfaction | The pain perception will be assessed using visual analog scale (VAS) immediately after wire insertion, at 4, 24 hours, 3 days, 7 days, and immediately after each monthly visit (0 no pain, 3 simple pain, 100 very sever pain). Pain sensitivity questionnaire (PSQ) will be used to assess the patient reliability to pain. This will be done using the Arabic version of PSQ (The patient answer no or yes) |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery.
• Patients who have cleft lip or palate, hypodontia, or hyperdontia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nawar A jebory, PHD student | Contact | 07809752102 | Iraq/ Baghdad | nooorznawar@gmail.com |
| Dheaa H Al-Groosh, PHD | Contact | 07737776503 | Iraq /Baghdad | dheaaha73@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Dheaa H Al-Groosh, PHD | University of Baghdad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nawar A jebory | Recruiting | Baghdad | Iraq |
randomized clinical trial
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Parallel Assignment
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Double (open label)
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| 1 year |