Orthodontic ApplianceNCT04378205
Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium
A study testing 0.014-inch NiTi on one side /0.018-inch NiTi on the other side and 0.016-inch NiTi on one side /0.018-inch NiTi on the other side in people with Orthodontic Appliance, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- 0.014-inch NiTi on one side /0.018-inch NiTi on the other side and 0.016-inch NiTi on one side /0.018-inch NiTi on the other side
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2018to 31 Dec 2019
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-25 years
- Class I skeletal malocclusion
- Mild lower arches crowding.
- Contact point displacement less than 2 mm.
- No previous orthodontic treatment
Who cannot join
- Missing teeth
- Poor oral hygiene
- deep carious teeth
- history of previous trauma
- any medical conditions affecting blood vessels
- smokers
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Dental Faculty/Jordan university of Science and Technology Dental Teaching Clinics
Irbid
About this study
Official title: Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial
to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.
Read the detailed description
Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.
Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).
- Conditions
- Orthodontic Appliance
- Being tested
- 0.014-inch NiTi on one side /0.018-inch NiTi on the other side, 0.016-inch NiTi on one side /0.018-inch NiTi on the other side
- Keywords
- Pulpal blood flow, Pfixed appliance, Alignment arch wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.014-inch NiTi on one side /0.018-inch NiTi on the other sideProcedure or surgery
Where each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.
0.016-inch NiTi on one side /0.018-inch NiTi on the other sideProcedure or surgery
Where each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.
| Study group | Role | What they receive |
|---|---|---|
| 0.014/0.018 NiTi arch wire | Experimental | 0.014-inch NiTi on one side /0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients Receives: Procedure: 0.014-inch NiTi on one side /0.018-inch NiTi on the other side |
| 0.016/0.018 NiTi arch wire | Experimental | 0.016-inch NiTi on one side / 0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients Receives: Procedure: 0.016-inch NiTi on one side /0.018-inch NiTi on the other side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal blood flow changes
Measurements were taken by the use of Laser Doppler Flowmeter mm/s
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ApplianceStudies 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. Each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group 1:- 0.014-inch and 0.018-inch NiTi Group 2:- 0.016-inch and 0.018-inch NiTi.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 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
- Investigators
- Elham Abu Alhaija, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378205
- Sponsor's protocol ID
- 39/2018
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04378205
- Acronym / sponsor ID
- 39/2018
- Conditions
- Orthodontic Appliance
- Keywords
- Pulpal blood flow, Pfixed appliance, Alignment arch wire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 May 2020 (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.
to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.
Detailed description
Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.
Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A split mouth study design was applied. Each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group 1:- 0.014-inch and 0.018-inch NiTi Group 2:- 0.016-inch and 0.018-inch NiTi.
| Arm | Type | Receives |
|---|---|---|
| 0.014/0.018 NiTi arch wire | Experimental | Procedure: 0.014-inch NiTi on one side /0.018-inch NiTi on the other side0.014-inch NiTi on one side /0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients |
| 0.016/0.018 NiTi arch wire | Experimental | Procedure: 0.016-inch NiTi on one side /0.018-inch NiTi on the other side0.016-inch NiTi on one side / 0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-25 years
- Class I skeletal malocclusion
- Mild lower arches crowding.
- Contact point displacement less than 2 mm.
- No previous orthodontic treatment
Key exclusion criteria (6 listed)
- Missing teeth
- Poor oral hygiene
- deep carious teeth
- history of previous trauma
- any medical conditions affecting blood vessels
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 |
|---|---|---|
| 0.014-inch NiTi on one side /0.018-inch NiTi on the other sideWhere each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch. | Procedure or surgery | 0.014/0.018 NiTi arch wire |
| 0.016-inch NiTi on one side /0.018-inch NiTi on the other sideWhere each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch. | Procedure or surgery | 0.016/0.018 NiTi arch wire |
Primary outcome
Pulpal blood flow changes
Time frame: up to 4 weeks
Measurements were taken by the use of Laser Doppler Flowmeter mm/s
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 7 May 2020.
- 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.
Elham Abu Alhaija, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.014-inch NiTi on one side /0.018-inch NiTi on the other side and 0.016-inch NiTi on one side /0.018-inch NiTi on the other side in people with Orthodontic Appliance, 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 5 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: finished, as of the sponsor's last update on 7 May 2020. 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 (time frame: up to 4 weeks). 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 7 May 2020.