Orthodontic AppliancesNCT03780764
Changes in Pulpal Blood Flow Between Conventional and Self-ligating Fixed Orthodontic Brackets During Leveling and Alignment Stage
A study testing A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets and Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets in people with Orthodontic Appliances, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement. Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliances
- What is being tested?
- A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets and Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2017to 1 May 2018
- 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 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both male and female subjects
- 6 or more years old
- Class I skeletal malocclusion
- mild lower arch crowding.
Who cannot join
- Poor oral hygiene
- Previous orthodontic treatment
- Active periodontal disease
- Missing teeth, deep carious teeth
- Teeth with root resorption
- Endodontically treated teeth
Show all 10Show fewer
- History of previous trauma
- Restoration on measured teeth
- Medical conditions affecting blood vessels and
- smoking
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Jordan University of science and technology Dental Teaching Clinics
Irbid
About this study
Official title: Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances
- Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.
Read the detailed description
Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.
Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.
- Conditions
- Orthodontic Appliances
- Being tested
- A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets, Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets
- Keywords
- Pulpal blood flow, self ligating brackets, orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription bracketsOther
A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8).
Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription bracketsOther
Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side.
| Study group | Role | What they receive |
|---|---|---|
| Conventional fixed appliance | Active comparator | A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch. Receives: Other: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets |
| Self ligating fixed appliance | Experimental | Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side. Receives: Other: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal blood flow changes by the use of Laser Doppler Flowmeter
millimeter per second
Measured: 20 minutes ,48 hours, 72 hours and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic AppliancesStudies of the same condition, open and under way.
- 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
- A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Abu Alhaija, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780764
- Sponsor's protocol ID
- 236/2016
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT03780764
- Acronym / sponsor ID
- 236/2016
- Conditions
- Orthodontic Appliances
- Keywords
- Pulpal blood flow, self ligating brackets, orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Dec 2018 (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.
- Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.
Detailed description
Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.
Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients).
| Arm | Type | Receives |
|---|---|---|
| Conventional fixed appliance | Active comparator | Other: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription bracketsA pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch. |
| Self ligating fixed appliance | Experimental | Other: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription bracketsSelf-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Both male and female subjects
- 6 or more years old
- Class I skeletal malocclusion
- mild lower arch crowding.
Key exclusion criteria (10 listed)
- Poor oral hygiene
- Previous orthodontic treatment
- Active periodontal disease
- Missing teeth, deep carious teeth
- Teeth with root resorption
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 |
|---|---|---|
| A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription bracketsA pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8). | Other | Conventional fixed appliance |
| Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription bracketsSelf-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side. | Other | Self ligating fixed appliance |
Primary outcome
Pulpal blood flow changes by the use of Laser Doppler Flowmeter
Time frame: 20 minutes ,48 hours, 72 hours and 1 month
millimeter per second
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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 A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets and Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets in people with Orthodontic Appliances, run by Jordan University of Science and Technology at 1 site in Jordan.
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 4 inclusion and 10 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 20 Dec 2018. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulpal blood flow changes by the use of Laser Doppler Flowmeter (time frame: 20 minutes ,48 hours, 72 hours and 1 month). 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 20 Dec 2018.