Skeletal and Dental CL I Malocclusion Moderate CrowdingNCT05978817
Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)
A study testing Damon Ultima bracket in people with Skeletal and Dental CL I Malocclusion Moderate Crowding, run by University of Baghdad at 1 site in Iraq.
Trial summary
Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal and Dental CL I Malocclusion Moderate Crowding
- What is being tested?
- Damon Ultima bracket
- 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 Aug 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Nawar A jebory
Baghdad
Nawar A jebory, 07809752102, nooorznawar@gmail.com
Dheaa H Al-Groosh, +9647737776503, dheaaha73@yahoo.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Damon Ultima bracket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damon Ultima bracketDevice
Also called conventional Roth appliance
It is metal twin bracket with their recommended arch wire
| Study group | Role | What they receive |
|---|---|---|
| Damon Ultima brackets | Experimental | Damon Ultima brackets Receives: Device: Damon Ultima bracket |
| conventional Roth appliance | Experimental | conventional Roth appliance Receives: Device: Damon Ultima bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal outcomes assessment
- 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal and Dental CL I Malocclusion Moderate CrowdingStudies 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawar Ahmed Abed, University of Baghdad
- Investigators
- Dheaa H Al-Groosh, PHD, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978817
- Sponsor's protocol ID
- Damon Ultima brack treatment
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: randomized clinical trial
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Damon Ultima Vs Conventional Brackets (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05978817
- Acronym / sponsor ID
- Damon Ultima brack treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 7 Aug 2023 (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.
Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Damon Ultima brackets | Experimental | Device: Damon Ultima bracketDamon Ultima brackets |
| conventional Roth appliance | Experimental | Device: Damon Ultima bracketconventional Roth appliance |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Damon Ultima bracketAlso: conventional Roth applianceIt is metal twin bracket with their recommended arch wire | Device | Damon Ultima brackets, conventional Roth appliance |
Primary outcome
Occlusal outcomes assessment
Time frame: 1 year
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
Little Irregularity index:
Time frame: 6 months
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
Arch parameter measurement:
Time frame: 1 year
Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch
Root alingment
Time frame: 1 year
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
Root resorption
Time frame: 1 year
Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs.
1 secondary outcome
Patient experience and satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No. randomized clinical trial
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.
Dheaa H Al-Groosh, PHD principal investigator
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 Damon Ultima bracket in people with Skeletal and Dental CL I Malocclusion Moderate Crowding, 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nawar A jebory, PHD student (07809752102 ext. Iraq/ Baghdad, nooorznawar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal outcomes assessment (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.