Orthodontic BracketsNCT07185087
Damon vs MBT Braces: Patient Compliance and Treatment Efficiency
A study testing passive self-ligating, Damon Ultima brackets and Conventional ligation, MBT brackets in people with Orthodontic Brackets, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Brackets
- What is being tested?
- passive self-ligating, Damon Ultima brackets and Conventional ligation, MBT brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIraq
- Study dates
- 1 Apr 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Treatment Progress and the Compliance of Patients Treated With DAMON Braces Versus Patients Treated With MBT Braces During Early Stage of Treatment: A Randomized Clinical Trial
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.
Read the detailed description
A single-operator, single-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted for patients seeking orthodontic treatment with fixed appliances. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Patients who meet the eligibility criteria will be randomly assigned to one of two bracket-type groups. To eliminate inter-operator variability, all patients will be treated by a single operator.
A standardized protocol will be followed. Each patient will undergo extraoral and intraoral photography, intraoral scanning with Medit i700 (Medit Corp., Seoul, South Korea), and radiographic evaluation (CBCT and lateral cephalogram). On bonding day, gingival index and plaque index will be assessed. All teeth will then be isolated and cleaned with a mixture of water and pumice using a rubber-polishing cup on a low-speed handpiece. The teeth will be rinsed and dried with an oil-free air syringe, and etched using the conventional acid-etching technique (37% orthophosphoric acid applied for 30 seconds). The surfaces will be thoroughly rinsed with water for 10 seconds to ensure complete removal of the etchant, in accordance with the manufacturer's instructions. The enamel will then be gently dried with air until a frosty-white appearance is observed.
A uniform coat of universal bonding primer (Ortho Solo, Ormco Corp., Glendora, California, USA) will be applied to the etched surfaces using a nylon bond brush. Each tooth will receive a gentle air blow for 2 seconds with the air stream directed perpendicular to the enamel surface. After etching and priming, a thin layer of adhesive (Green Glow, Ormco Corp., Glendora, California, USA) will be applied to the mesh base of each bracket, which will be positioned on the buccal surface of the tooth using a bracket holder. The bracket height will be determined according to the manufacturer's instructions. Any excess adhesive will be carefully removed from around the base of the bracket with a dental probe prior to curing, without disturbing the seated bracket. The adhesive will then be light-cured for 20 seconds.
In the intervention group, Damon Ultima brackets (Ormco Corp., Glendora, California, USA) will be bonded from the second molar to the second molar in each arch. In the comparison group, MBT Mini Diamond brackets (Ormco Corp., Glendora, California, USA) will be bonded from the second molar to the second molar in each arch. Damon Ultima archwires (Ormco Corp., Glendora, California, USA) will be used for both groups in the following sequence: 0.014-inch CuNiTi, 0.018-inch CuNiTi, and 0.014 × 0.0275-inch CuNiTi.
All patients will receive an oral hygiene kit, a brochure on dietary recommendations, and a printed questionnaire to assess pain during treatment (developed for the study). Patients will be reviewed every 8 weeks, during which gingival index, plaque index, photographs, intraoral scans, and questionnaires will be collected. Patients will also be instructed to contact the operator immediately and attend as soon as possible in the event of bracket bond failure. The treatment will be followed up for 6 months.
- Conditions
- Orthodontic Brackets
- Being tested
- passive self-ligating, Damon Ultima brackets, Conventional ligation, MBT brackets
- Keywords
- Damon Ultima, Patient Compliance, MBT bracket, leveling and alignment
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive self-ligating, Damon Ultima bracketsDevice
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).
Conventional ligation, MBT bracketsDevice
Patients will receive MBT Mini Diamond brackets (Ormco Corp., Glendora, California, USA) bonded in the same manner, with the same archwire sequence.
| Study group | Role | What they receive |
|---|---|---|
| Damon | Experimental | Damon Ultima Self-ligating Brackets Receives: Device: passive self-ligating, Damon Ultima brackets |
| MBT | Active comparator | MBT Mini Diamond Conventional brackets Receives: Device: Conventional ligation, MBT brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
Changes in Oral Hygiene and Gingival Health During Treatment
Description: Assessment of oral hygiene and gingival health status during treatment. A composite score will be calculated by averaging Plaque Index (Silness \& Löe) and Gingival Index (Löe \& Silness) values.
Time Frame: At each follow-up visit during the alignment stage (up to 6 months).
Method: Plaque Index and Gingival Index, combined into a single composite score.
Unit of Measure: Composite oral hygiene score.
Measured: 6 months
Incidence of Bracket Bonding Failures During Treatment
Description: Number of bracket debonding incidents per patient during treatment.
Time Frame: Throughout the alignment stage (up to 6 months).
Method: Clinical records of bonding failure incidence.
Unit of Measure: Number of debonded brackets per patient
Measured: 6 months
Patient Pain Perception During Orthodontic Treatment
Description: Evaluation of patient pain perception during orthodontic treatment.
Time Frame: After appliance placement and at specified time intervals during the alignment stage (up to 6 months).
Method: Visual Analogue Scale (VAS).
Unit of Measure: VAS score (0-10 scale).
Measured: 6 months
Patient-Reported Smile Attractiveness and Confidence
Description: Assessment of patients' self-perception of smile aesthetics, confidence, and impact of orthodontic treatment on quality of life. Responses are collected using a structured questionnaire with multiple-choice and Likert-type questions (e.g., agreement scales, confidence levels, frequency of behaviors).
Time Frame: Before treatment and at different time intervals during the alignment stage (up to 6 months).
Method: Self-administered questionnaire developed for the study. Unit of Measure: Proportion of patients selecting each response category.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Apr 2025
- Primary completion25 Oct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthodontic BracketsStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehan Fadhil IBrahim, University of Baghdad
- Investigators
- Jehan F. IBrahim, Principal investigator, University of BaghdadHadeel A. Al-lami, Asst Prof., Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185087
- Sponsor's protocol ID
- Damon vs MBT brackets
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan to Share IPD because this trial is a prospective study and yet we can't promise for any sharing
Publications
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.
PubMed 32215477Coenen 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.
PubMed 36308300Barbosa 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.
PubMed 29713922Jahanbin 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.
PubMed 32190212
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Progress and the Compliance of Patients Treated With DAMON Braces Versus Patients Treated With MBT Braces During Early Stage of Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07185087
- Acronym / sponsor ID
- Damon vs MBT brackets
- Conditions
- Orthodontic Brackets
- Keywords
- Damon Ultima, Patient Compliance, MBT bracket, leveling and alignment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A single-operator, single-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted for patients seeking orthodontic treatment with fixed appliances. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Patients who meet the eligibility criteria will be randomly assigned to one of two bracket-type groups. To eliminate inter-operator variability, all patients will be treated by a single operator.
A standardized protocol will be followed. Each patient will undergo extraoral and intraoral photography, intraoral scanning with Medit i700 (Medit Corp., Seoul, South Korea), and radiographic evaluation (CBCT and lateral cephalogram). On bonding day, gingival index and plaque index will be assessed. All teeth will then be isolated and cleaned with a mixture of water and pumice using a rubber-polishing cup on a low-speed handpiece. The teeth will be rinsed and dried with an oil-free air syringe, and etched using the conventional acid-etching technique (37% orthophosphoric acid applied for 30 seconds). The surfaces will be thoroughly rinsed with water for 10 seconds to ensure complete removal of the etchant, in accordance with the manufacturer's instructions. The enamel will then be gently dried with air until a frosty-white appearance is observed.
A uniform coat of universal bonding primer (Ortho Solo, Ormco Corp., Glendora, California, USA) will be applied to the etched surfaces using a nylon bond brush. Each tooth will receive a gentle air blow for 2 seconds with the air stream directed perpendicular to the enamel surface. After etching and priming, a thin layer of adhesive (Green Glow, Ormco Corp., Glendora, California, USA) will be applied to the mesh base of each bracket, which will be positioned on the buccal surface of the tooth using a bracket holder. The bracket height will be determined according to the manufacturer's instructions. Any excess adhesive will be carefully removed from around the base of the bracket with a dental probe prior to curing, without disturbing the seated bracket. The adhesive will then be light-cured for 20 seconds.
In the intervention group, Damon Ultima brackets (Ormco Corp., Glendora, California, USA) will be bonded from the second molar to the second molar in each arch. In the comparison group, MBT Mini Diamond brackets (Ormco Corp., Glendora, California, USA) will be bonded from the second molar to the second molar in each arch. Damon Ultima archwires (Ormco Corp., Glendora, California, USA) will be used for both groups in the following sequence: 0.014-inch CuNiTi, 0.018-inch CuNiTi, and 0.014 × 0.0275-inch CuNiTi.
All patients will receive an oral hygiene kit, a brochure on dietary recommendations, and a printed questionnaire to assess pain during treatment (developed for the study). Patients will be reviewed every 8 weeks, during which gingival index, plaque index, photographs, intraoral scans, and questionnaires will be collected. Patients will also be instructed to contact the operator immediately and attend as soon as possible in the event of bracket bond failure. The treatment will be followed up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Damon | Experimental | Device: passive self-ligating, Damon Ultima bracketsDamon Ultima Self-ligating Brackets |
| MBT | Active comparator | Device: Conventional ligation, MBT bracketsMBT Mini Diamond Conventional brackets |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive self-ligating, Damon Ultima bracketsPatients 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). | Device | Damon |
| Conventional ligation, MBT bracketsPatients will receive MBT Mini Diamond brackets (Ormco Corp., Glendora, California, USA) bonded in the same manner, with the same archwire sequence. | Device | MBT |
Primary outcome
Degree of orthodontic treatment improvement assessed using ABO Discrepancy Index
Time frame: 6 months
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
Reduction in Malocclusion Assessed by Peer Assessment Rating (PAR) Index
Time frame: 6 months
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
Improvement in Malocclusion Severity Assessed by Index of Orthodontic Treatment Need (IOTN-DHC)
Time frame: 6 months
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.
4 secondary outcomes
Changes in Oral Hygiene and Gingival Health During Treatment
Time frame: 6 months
Incidence of Bracket Bonding Failures During Treatment
Time frame: 6 months
Patient Pain Perception During Orthodontic Treatment
Time frame: 6 months
Patient-Reported Smile Attractiveness and Confidence
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 32215477Moyano 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.
- Background: PubMed 36308300Coenen 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.
- Background: PubMed 29713922Barbosa 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.
- Background: PubMed 32190212Jahanbin 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.
- Individual participant dataSharing planned: No. No Plan to Share IPD because this trial is a prospective study and yet we can't promise for any sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jehan F. IBrahim principal investigator
University of Baghdad
Hadeel A. Al-lami, Asst Prof. study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive self-ligating, Damon Ultima brackets and Conventional ligation, MBT brackets in people with Orthodontic Brackets, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of orthodontic treatment improvement assessed using ABO Discrepancy Index (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07185087, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.