Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)

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

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

Study Overview

• Status: Recruiting
• Conditions: Skeletal and Dental CL I Malocclusion Moderate Crowding
• Intervention / Treatment: Device: Damon Ultima bracket

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nawar A jebory, PHD student; Phone Number: Iraq/ Baghdad 07809752102; Email: nooorznawar@gmail.com
• Study Contact Backup: Name: Dheaa H Al-Groosh, PHD; Phone Number: Iraq /Baghdad 07737776503; Email: dheaaha73@yahoo.com

Study Locations

• Iraq
  • Baghdad, Iraq
    • Recruiting
    • Nawar A jebory
    • Contact: Nawar A jebory; Phone Number: 07809752102; Email: nooorznawar@gmail.com
    • Contact: Dheaa H Al-Groosh; Phone Number: +9647737776503; Email: dheaaha73@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Damon Ultima brackets	Device: Damon Ultima bracket; It is metal twin bracket with their recommended arch wire; Other Names: conventional Roth appliance
Experimental: conventional Roth appliance	Device: Damon Ultima bracket; It is metal twin bracket with their recommended arch wire; 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

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Dheaa H Al-Groosh, PHD, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: Damon Ultima brack treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: randomized clinical trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No