Title Comparative Evaluation of Treatment Outcomes between Damon Ultima and Pitts 21 Pro Bracket Systems; A Randomized Clinical Trial Abstract Background: The primary advantages of self-ligation brackets include faster archwire removal and ligation, reduced or eliminated need for chairside assistance, secure archwire engagement, and lower bracket-archwire friction, which collectively contribute to a substantial reduction in resistance to sliding and are theorized to enhance the efficiency of initial tooth alignment. This randomized controlled trial (RCT) will be conducted to assess differences in treatment outcomes with these two different self-ligation bracket systems.
Subjects/Materials and Methods: This randomized clinical trial included 40 participants with full permanent dentition (excluding third molars) exhibiting Angle Class I malocclusion with moderate crowding. Patients who were scheduled to undergo orthodontic treatment were allocated into two groups: Damon Ultima and Pitts 21 Pro. The total treatment duration will be measured in months from the bonding day to the completion of treatment, in addition to the number of visits.
Pre-treatment, post-alignment, and post-treatment records were obtained, including intraoral scans (IOS) for assessing alignment efficiency and arch parameters. Periapical radiographs of the upper and lower incisors were taken before and after treatment to measure the amount of root resorption. Treatment outcomes were evaluated using the American Board of Orthodontics (ABO) grading system. Additionally, pain perception and patient treatment perception were assessed.
Presence of full permanent dentition except the third molars.
Class I with moderate crowding requiring fixed appliance therapy and don't need extraction.
Good dental hygiene and periodontal health.
Good general health; no systemic conditions affecting bone metabolism or pain perception.
Severe skeletal discrepancies requiring orthognathic surgery, craniofacial anomalies). Patients with active periodontal disease or medically compromised patients.
Parallel
Treatment outcome of Damon ultima
DeviceTo compare treatment outcome including duration, root resorption, arch dimension, pain and quality of finishing
Treatment outcome of pitt21 pro
DeviceTo compare treatment outcome including duration, root resorption, arch dimension, pain and quality of finishing
To compare the total treatment time between Damon Ultima and Pitts 21 Pro bracket systems.
To compare the total treatment time between Damon Ultima and Pitts 21 Pro bracket systems from the day of bracket bonding to the day of debonding.
Alignment efficiency
1\. Comparing alignment efficiency (measured by Little's irregularity index reduction rate) after each visit between Damon Ultima and Pitts 21 Pro bracket systems and the time taken to reach a well-aligned dental arch.
2. Comparison of pain perception
Patient-reported pain scores will be assessed during the first week following bracket bonding and after first rectangular wire using a 10-cm Visual Analogue Scale (VAS) between Damon Ultima and Pitts 21 Pro bracket systems
the amount of orthodontically induced inflammatory root resorption (OIIRR)
compare the amount of orthodontically induced inflammatory root resorption (OIIRR) in the apical region of maxillary and mandibular incisors at start of treatment and at finishing.
Evaluating the dental arch dimensions
Measure arch length and widths (inter-canine, inter premolar and inter-molar widths) on digital models before treatment, after leveling/alignment, and at debonding.
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