MalocclusionNCT02959671
Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
A study testing Lower Anterior EXD-952 Self-ligating Brackets in people with Malocclusion, run by University of Minnesota at 1 site in United States.
Trial summary
A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Malocclusion
- What is being tested?
- Lower Anterior EXD-952 Self-ligating Brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars)
- Mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide
Who cannot join
- Mental/emotional/developmental disability
- Inability to give informed consent
- Cleft lip and/or palate, craniofacial anomaly, or syndrome
- Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
- Prosthodontic or restored substrate extending on the labial surface of mandibular incisors
- Deep bite
- Known allergies to any study materials
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires.
A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead. Other mandibular brackets will remain in place. Tooth movement will be performed using 0.019x0.025" Stainless Steel archwires.
Read more
In both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed.
The evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2).
After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place until the orthodontic treatment is completed.
- Conditions
- Malocclusion
- Being tested
- Lower Anterior EXD-952 Self-ligating Brackets
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Anterior EXD-952 Self-ligating BracketsDevice
Placement of EXD-952 Self-ligating Brackets on mandibular incisors
| Study group | Role | What they receive |
|---|---|---|
| Lower Anterior EXD-952 Self-ligating Brackets | Experimental | Not described Receives: Device: Lower Anterior EXD-952 Self-ligating Brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bracket Door Stability
The stability of the bracket door is assessed at the time of bracket placement. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors across all participants that break at bracket placement. Number of total broken bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."
Measured: baseline
Ability of Door to Successfully Hold the Archwire in the Bracket Slot
The ability of door to hold the archwire in the bracket slot is assessed at the time of bracket placement. If the door is unable to hold the archwire, then spontaneous door opening occurs. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors that successfully held the archwire within the bracket slot at bracket placement. Number of successful bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."
Measured: baseline
Bracket's Ability to Rotate Teeth
The bracket's ability to rotate teeth will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate rotational correction as adequate or not adequate. Outcome is reported as the percent of participants for whom the clinician rated rotational correction as adequate.
Measured: 6-8 weeks
Clinicians' Satisfaction With the Bracket
The clinician's satisfaction with the bracket will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants for whom the clinician rated bracket satisfaction as somewhat satisfied or very satisfied.
Measured: 6-8 weeks
Patient Comfort in Comparison With Other Brackets (Questionnaire)
The patient's comfort in comparison with other brackets will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Patients will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants who rated their comfort in comparison with other brackets as somewhat satisfied or very satisfied.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- 3M Oral Care
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959671
- Sponsor's protocol ID
- 1611M00321
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2016
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
- ClinicalTrials.gov ID
- NCT02959671
- Acronym / sponsor ID
- 1611M00321
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- 3M Oral Care
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 14 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires.
A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead. Other mandibular brackets will remain in place. Tooth movement will be performed using 0.019x0.025" Stainless Steel archwires.
In both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed.
The evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2).
After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place until the orthodontic treatment is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Anterior EXD-952 Self-ligating Brackets | Experimental | Device: Lower Anterior EXD-952 Self-ligating Brackets |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars)
- Mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide
Key exclusion criteria (7 listed)
- Mental/emotional/developmental disability
- Inability to give informed consent
- Cleft lip and/or palate, craniofacial anomaly, or syndrome
- Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
- Prosthodontic or restored substrate extending on the labial surface of mandibular incisors
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 |
|---|---|---|
| Lower Anterior EXD-952 Self-ligating BracketsPlacement of EXD-952 Self-ligating Brackets on mandibular incisors | Device | Lower Anterior EXD-952 Self-ligating Brackets |
Primary outcome
Bracket Door Stability
Time frame: baseline
The stability of the bracket door is assessed at the time of bracket placement. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors across all participants that break at bracket placement. Number of total broken bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."
Ability of Door to Successfully Hold the Archwire in the Bracket Slot
Time frame: baseline
The ability of door to hold the archwire in the bracket slot is assessed at the time of bracket placement. If the door is unable to hold the archwire, then spontaneous door opening occurs. Each bracket has 4 doors. Outcome is reported as the percent of bracket doors that successfully held the archwire within the bracket slot at bracket placement. Number of successful bracket doors/number of total bracket doors across all participants * 100. Unit of measure is "percentage of bracket doors."
Bracket's Ability to Rotate Teeth
Time frame: 6-8 weeks
The bracket's ability to rotate teeth will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate rotational correction as adequate or not adequate. Outcome is reported as the percent of participants for whom the clinician rated rotational correction as adequate.
Clinicians' Satisfaction With the Bracket
Time frame: 6-8 weeks
The clinician's satisfaction with the bracket will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Clinician will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants for whom the clinician rated bracket satisfaction as somewhat satisfied or very satisfied.
Patient Comfort in Comparison With Other Brackets (Questionnaire)
Time frame: 6-8 weeks
The patient's comfort in comparison with other brackets will be assessed after the first archwire change (expected 6-8 weeks after initial bonding). Patients will rate their satisfaction on a 5-point Likert scale (Very unsatisfied, somewhat unsatisfied, neutral, somewhat satisfied, very satisfied). A rating of 4 (somewhat satisfied) or 5 (very satisfied) is considered successful. Outcome is reported as the percent of participants who rated their comfort in comparison with other brackets as somewhat satisfied or very satisfied.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Anterior EXD-952 Self-ligating Brackets in people with Malocclusion, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jan 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bracket Door Stability (time frame: baseline). 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 14 Jan 2021.