Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)

Study Overview
=================
Brief Summary
-----------------
Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Effectiveness of Damon Ultima Vs Conventional Brackets (A Randomized Clinical Trial)

Conditions
-----------------
Skeletal and Dental CL I Malocclusion Moderate Crowding

Intervention / Treatment
-----------------
* Device: Damon Ultima bracket


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics. Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment. Presence of all the permanent teeth apart from the third molars. Patients with good oral hygiene and periodontal health. Without previous orthodontic treatment/ functional appliances 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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Damon Ultima brackets<br>Damon Ultima brackets | Device: Damon Ultima bracket<br>* It is metal twin bracket with their recommended arch wire<br>* Other names: conventional Roth appliance;|
| Experimental: conventional Roth appliance<br>conventional Roth appliance | Device: Damon Ultima bracket<br>* It is metal twin bracket with their recommended arch wire<br>* Other names: conventional Roth appliance;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 1 year |