Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems

Comparative Evaluation of Treatment Outcomes between Damon Ultima and Pitts 21 Pro Bracket Systems:

A Randomized Clinical Trial

A Protocol Submitted to the Council of the College of Dentistry, University of Baghdad in Partial Fulfillment of Requirements for the Degree of Doctor of Philosophy in Orthodontics By Hussain Jabar Kadhem B.D.S., M.Sc. (Orthodontics)

Supervised by:

Professor Dr. Mohammed Nahidh B.D.S, M.Sc., Ph.D. (Orthodontics)

Introduction Self-ligating brackets eliminate the need for elastic or wire ligatures by utilizing an integrated opening-and-closing mechanism that holds the archwire in place. Their primary advantages 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 .

Previous retrospective studies have shown that the use of self-ligating brackets can reduce treatment times by 4 to 6 months and by 4 to 7 visits when compared with conventional brackets . However, these studies are prone to bias, such as selection, outcome, and recall bias, and confounders.

Although improved treatment efficiency is highly desirable, it has not been a universal finding, particularly for initial alignment and space closure. Some studies have found no difference in the rate of initial alignment with either conventional or self-ligating brackets and have usually compared passive self-ligating brackets with conventional brackets .

Some self-ligating brackets designs can be bulkier, and the sliding mechanism may be prone to binding or breakage, requiring careful clinical management. The claimed clinical superiority, particularly regarding treatment duration, remains a contentious point within the orthodontic literature .

Self-ligating brackets are categorized into two main types: Passive systems, where the clip does not actively exert force on the archwire (e.g., Damon), and Active systems, where the closing mechanism acts as a spring to engage the archwire (e.g., In-Ovation). The choice between systems depends on the desired level of force and control .

Two modern passive self ligating systems are available now namely; Damon Ultima from Ormco, USA and Pitts 21 Pro from OC Orthodontics, USA.

Damon claimed that this system is the first true full expression orthodontic system designed for faster and more precise finishing. Its revolutionary design allows for precise control of rotation, angulation, and torque. The round-sided rectangular Damon Ultima archwire engagement at the horizontal contact points delivers earlier rotation control. Angulation is resolved earlier with vertical contacts, while the engagement at vertical contact points delivers torque control and full expression of the prescription with lighter forces.

On the other hand; Pitts 21 system uses a progressive variation in slot dimensions, transitioning from a square slot (0.021" × 0.021") in the anterior region to a rectangular slot in the posterior portion of the arch-0.021" × 0.023" for premolars and 0.021" × 0.024" for molars. The system claims that this early control of the anterior teeth, achieved through the "Engage Early" wire, allows fuller engagement as early as the second or third appointment without the higher force levels typically associated with large cross-section rectangular archwires, while still providing increased freedom of movement for the posterior teeth .

Finite element analysis comparing Damon Q (rectangular slot) and Pitts 21 (square slot) found that torque moment values, torque expression and Von Mises stress were higher in Pitts 21 brackets at all incisal inclinations .

The systematic review demonstrated that self-ligating brackets do not provide any clinically meaningful reduction in either overall treatment duration or the number of patient visits when compared with conventional bracket systems. Also, most clinical trials comparing self ligating brackets with conventional ligated systems have shown no significant differences in treatment duration, number of appointments or treatment outcomes . Pain perception during initial alignment appears similar between different passive self ligating systems; in a randomized trial comparing Smart Clip and Damon Q, with pain peaked in the first two days . External apical root resorption after treatment with Damon brackets was comparable to conventional brackets .

Comparisons between Damon Ultima and Pitts 21 brackets have not been reported in the literature. Both systems differ in slot geometry and prescribed archwires, which may influence torque, alignment efficiency and arch development. This randomized controlled trial (RCT) will be conducted to assess differences in treatment outcomes with these two bracket systems.

Aim and Objectives Aim The aim of this study will to compare the treatment outcomes of Damon Ultima and Pitts 21 Pro bracket systems.

Primary objective 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.

Secondary objectives

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). 3. To 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. 4. 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. 5. Recording bracket debonding events and compare failure rates between systems. 6. Evaluating the quality of finished cases using the American Board of Orthodontics - Objective Grading System (ABO-OGS) to grade digital model.

The null hypothesis The null hypothesis I There is no significant difference in treatment duration between patients treated with Damon Ultima brackets and those treated with Pitts 21 Pro brackets.

The null hypothesis II There is no significant difference in alignment efficiency between Damon Ultima and Pitts 21 Pro bracket systems.

The null hypothesis III There is no significant difference in pain perception during treatment between Damon Ultima and Pitts 21 Pro brackets.

The null hypothesis IV There is no significant difference in the amount of external apical root resorption between Damon Ultima and Pitts 21 Pro bracket systems.

The null hypothesis V There is no significant difference in changes in dental arch dimensions between Damon Ultima and Pitts 21 Pro brackets.

The null hypothesis VI There is no significant difference in bracket failure rate between Damon Ultima and Pitts 21 Pro bracket systems.

The null hypothesis VII:

There is no significant difference in bracket failure rate between Damon Ultima and Pitts 21 Pro bracket systems.

Methodology Study design A multi centers, prospective, parallel groups randomized clinical trial with equal allocation to Damon Ultima and Pitts 21 pro systems. The trial will follow CONSORT guidelines for reporting (Figure 1).

Setting This study will be conducted in the orthodontic clinic in the College of Dentistry/ University of, as well as in governmental and private orthodontic centers.

Sample size The sample size was calculated with an alpha level of 5% and 80% power to detect a difference of 3 months in the total duration of treatment, according to the previous data . This revealed that 18 patients in each trial arm would be sufficient to detect this clinical difference (totals 36 patients). In order to account for 10% of dropouts, a total of 40 patients was decided to be collected.

Randomization Participants will be randomly assigned (1:1) to Damon Ultima or Pitts 21 pro using computer generated random blocks of varying sizes (prepared by an independent statistician). Allocation will be concealed in sealed opaque envelopes.

Blinding Operator blinding is not feasible due to the visibly different bracket designs. However, the examiners responsible for assessing outcomes will be blinded to group allocation. This will be achieved by concealing patient names and replacing them with coded numbers, ensuring that the examiner remains unaware of the treatment group.

Intervention procedures The same bonding protocol was applied for all patients, using identical bonding materials (Ormco Enlight Bonding System with Ortho Solo as the primer/bonding agent and 37% phosphoric acid etching gel \[FGM, Florida, USA\]). Etching was performed for 20 seconds, and curing was carried out using a light-curing unit (Woodpecker, Guilin, China). Smile Arc Protection (SAP) was followed, with minor modifications according to individual case requirements.

Damon Ultima group: Teeth will be bonded with Damon Ultima bracket system. Archwire sequence will be: 0.014 inch CuNiTi, 0.018-inch CuNiTi, 0.014×0.0275-inch CuNiTi and 0.018×0.0275-inch CuNiTi archwires, and 0.019×0.0275-inch stainless steel Ultima finishing archwires.

Pitts 21 Pro group: Teeth will be bonded with Pitts 21 Pro bracket system. Archwire sequence: 0.014-inch thermally Activated NiTi, 0.018 × 0.018-inch thermally Activated NiTi, 0.020×0.020-inch Thermally Activated NiTi, and 0.019 × 0.019-inch stainless steel.

Clinical management Appointment intervals will be scheduled every 8 weeks. Treatment mechanics, including use of inter-arch elastics, bite raiser, and finishing procedures will be standardized. All patients will receive oral hygiene instructions at each visit. In case of bracket failure, brackets will be rebonded using the same system within 3 days, otherwise the case would be considered as dropout.

The case considers as finish if achieve optimal functional occlusion, stable tooth positions, and high-quality esthetics at the end of treatment. Key criteria include establishing Class I molar and canine relationships, normal overjet and overbite, and well-distributed bilateral occlusal contacts without interferences.

Final alignment should show no rotations or spacing, leveled marginal ridges, proper buccolingual inclination, coordinated arch forms, corrected midlines, and a leveled curve of Spee. Esthetic requirements include a consonant smile arc, harmonious tooth proportions, appropriate incisor display, and symmetrical gingival contours.

Outcome measurements and data collection Total treatment duration: It will be measured in months from bonding day to the end of treatment in addition to number of visits.

• Alignment efficiency [Срок оценки: up to 6 month]
• 2. Comparison of pain perception [Срок оценки: through study completion, an average of 2 year]
• the amount of orthodontically induced inflammatory root resorption (OIIRR) [Срок оценки: through study completion, an average of 2 year]
• Evaluating the dental arch dimensions [Срок оценки: through study completion, an average of 2 year]
• bracket debonding events [Срок оценки: through study completion, an average of 2 year]
• 6. Evaluating the quality of finished case. [Срок оценки: through study completion, an average of 2 year]