Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems

NCT07318623 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 1155425
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Orthodontic Brackets; Orthodontic Pathological Resorption of External Root; Orthodontic Pain; Orthodentic Appliances

Outcome Measures

Primary Outcomes (1)

• 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.

  24 month

Secondary Outcomes (6)

• Alignment efficiency

  up to 6 month

• 2. Comparison of pain perception

  through study completion, an average of 2 year

• the amount of orthodontically induced inflammatory root resorption (OIIRR)

  through study completion, an average of 2 year

• Evaluating the dental arch dimensions

  through study completion, an average of 2 year

• bracket debonding events

  through study completion, an average of 2 year

Study Arms (2)

Damon ultima bracket group

ACTIVE COMPARATOR

Treatment outcome of Damon ultima bracket

Device: Treatment outcome of Damon ultima

Pitt21 pro bracket group

ACTIVE COMPARATOR

Treatment outcome of Pitt21 pro bracket

Device: Treatment outcome of pitt21 pro

Interventions

Treatment outcome of Damon ultima DEVICE

To compare treatment outcome including duration, root resorption, arch dimension, pain and quality of finishing

Damon ultima bracket group

Treatment outcome of pitt21 pro DEVICE

To compare treatment outcome including duration, root resorption, arch dimension, pain and quality of finishing

Pitt21 pro bracket group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Normal crown size and shape.
• No prior orthodontic treatment.
• Patient has a normal level of vitamin D3 in testing (Vit D3 serum level should be \>30).

You may not qualify if:

• Severe skeletal discrepancies requiring orthognathic surgery, craniofacial anomalies). Patients with active periodontal disease or medically compromised patients.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (2)

Collage of dentistry College of Dentistry/ University of Baghdad

Baghdad, Iraq

Location

Collage of dentistry College of Dentistry/ University of Baghdad

Baghdad, Iraq

Location

Study Officials

• Hussain Jabar

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hussain Jabar

CONTACT

009647807290383; hussain.jabardentist@gmail.com

Mohammed Nahidh

CONTACT

009647702551616; m_nahidh79@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant teacher

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 6, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

IR (2)