Damon vs MBT Braces: Patient Compliance and Treatment Efficiency

NCT07185087 | Active Not Recruiting

• 1 other identifier: Damon vs MBT brackets
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison between two bracket prescription systems, MBT and DAMON Ultima brackets and evaluate whether the changes incorporated in DAMON Ultima brackets can drive earlier improvement on teeth position, clinically visual progression of treatment, during initial stage of treatment. Another aim of this study is the effect of chosen bracket system on patient compliance.

Conditions

Orthodontic Brackets

Keywords

Damon Ultima; Patient Compliance; MBT bracket; leveling and alignment

Outcome Measures

Primary Outcomes (3)

• Degree of orthodontic treatment improvement assessed using ABO Discrepancy Index

  Description: Evaluation of improvement in tooth rotation/alignment, overjet, overbite, occlusal relationship, interproximal contact, and cephalometric parameters. Time Frame: At multiple time intervals during the alignment stage (up to 6 months). Method: American Board of Orthodontics Discrepancy Index scoring system. Unit of Measure: DI points

  6 months

• Reduction in Malocclusion Assessed by Peer Assessment Rating (PAR) Index

  Description: Measurement of the rate of dental alignment during treatment. Time Frame: At multiple time intervals during the alignment stage (up to 6 months). Method: Standardized PAR scoring applied to digital dental casts. Unit of Measure: PAR score

  6 months

• Improvement in Malocclusion Severity Assessed by Index of Orthodontic Treatment Need (IOTN-DHC)

  Description: Comparison of treatment need improvement before treatment and after completion of the alignment stage. Time Frame: Baseline and after alignment stage (approximately 6 months). Method: IOTN-DHC assessment. Unit of Measure: IOTN grade.

  6 months

Secondary Outcomes (4)

• Changes in Oral Hygiene and Gingival Health During Treatment

  6 months

• Incidence of Bracket Bonding Failures During Treatment

  6 months

• Patient Pain Perception During Orthodontic Treatment

  6 months

• Patient-Reported Smile Attractiveness and Confidence

  6 months

Study Arms (2)

Damon

EXPERIMENTAL

Damon Ultima Self-ligating Brackets

Device: passive self-ligating, Damon Ultima brackets

MBT

ACTIVE COMPARATOR

MBT Mini Diamond Conventional brackets

Device: Conventional ligation, MBT brackets

Interventions

passive self-ligating, Damon Ultima brackets DEVICE

Patients will receive Damon Ultima self-ligating brackets (Ormco Corp., Glendora, California, USA) bonded from the second molar to the second molar in each arch. Archwires will follow a standardized sequence: 0.014-inch CuNiTi, 0.018-inch CuNiTi, and 0.014 × 0.0275-inch CuNiTi (Ormco Corp., Glendora, California, USA). All bonding procedures will follow a standardized protocol, including enamel cleaning, acid etching, primer application (Ortho Solo), and adhesive curing (Green Glow).

Damon

Conventional ligation, MBT brackets DEVICE

Patients will receive MBT Mini Diamond brackets (Ormco Corp., Glendora, California, USA) bonded in the same manner, with the same archwire sequence.

MBT

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Both gender
• Age range between 16-40years of age.
• ANB angle not \<1° and not \>5°.
• Mild to moderate crowding, spacing and rotation.
• Requiring non-extraction treatment.
• The patient agreed to be part of this study.

You may not qualify if:

• A history of previous orthodontic treatment with fixed appliance.
• Permanent teeth extraction except third molar.
• Congenital anomaly.
• Cleft lip and palate patients.
• Patients with ectopic canine or other teeth.
• Patients with severe crowding (\<6mm).

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad/ Collage of Dentistry

Baghdad, Iraq, 10047, Iraq

Location

Related Publications (4)

• Moyano J, Montagut D, Perera R, Fernandez-Bozal J, Puigdollers A. Comparison of changes in the dental transverse and sagittal planes between patients treated with self-ligating and with conventional brackets. Dental Press J Orthod. 2020 Jan-Feb;25(1):47-55. doi: 10.1590/2177-6709.25.1.047-055.oar.

  PMID: 32215477 BACKGROUND

• Coenen FA, Bartz JR, Niederau C, Craveiro RB, Knaup I, Wolf M. Orthodontic treatment quality evaluated by partially automated digital IOTN and PAR index determination: a retrospective multicentre study. Eur J Orthod. 2023 May 31;45(3):308-316. doi: 10.1093/ejo/cjac064.

  PMID: 36308300 BACKGROUND

• Barbosa IV, Ladewig VM, Almeida-Pedrin RR, Cardoso MA, Santiago Junior JF, Conti ACCF. The association between patient's compliance and age with the bonding failure of orthodontic brackets: a cross-sectional study. Prog Orthod. 2018 May 1;19(1):11. doi: 10.1186/s40510-018-0209-1.

  PMID: 29713922 BACKGROUND

• Jahanbin A, Hasanzadeh N, Khaki S, Shafaee H. Comparison of self-ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):281-288. doi: 10.15171/joddd.2019.043.

  PMID: 32190212 BACKGROUND

Related Links

• "The Value of Self-Ligating Brackets in Orthodontics: About the Damon Protocol" (October 2021) - a chapter in Current Trends in Orthodontics by Suvetha Siva, Shreya Kishore, Suganya Dhanapal, and others

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jehan F. IBrahim

  University of Baghdad

  PRINCIPAL INVESTIGATOR

• Hadeel A. Al-lami, Asst Prof.

  University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthodontics Department, University of Baghdad

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 22, 2025
• Study Start: April 1, 2025
• Primary Completion: October 25, 2025
• Study Completion: December 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)