Orthodontic ApplianceNCT04549987
Speed of Premolar Extraction Space Closure: Every Visit Replacement of Working Archwire
A study testing Space closure without changing working archwire monthly and Space closure withchanging working archwire monthly in people with Orthodontic Appliance, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration… Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- Space closure without changing working archwire monthly and Space closure withchanging working archwire monthly
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteJordan
- Study dates
- 1 Dec 2018to 31 Aug 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥ 16 years
- Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o)
- Mild upper and lower arch crowding (<4mm) or no crowding
- Need for upper and lower first premolars extraction
- Skeletal I malocclusion (1<ANB <5)
- Average lower facial height and maxillomandibular plane angle (22 o <MM<32 o)
- Class I canine relationship
- Good oral hygiene and healthy periodontium
Who cannot join
- Poor oral hygiene
- Diseases and medications that were likely to affect bone biology
- Previous orthodontic treatment
- Evidence of bone loss
- Active periodontal disease
- Smoking
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics
Irbid
About this study
Official title: Speed of Premolar Extraction Space Closure: The Effect of Every Visit Replacement of Working Arch Wire - A Prospective Randomized Clinical Trial
The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure.
Read the detailed description
The aims were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro and to assess its effect on rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure and to compare the rate of teeth movement into fresh and old extraction sites.
Trial design: Randomized controlled clinical trial with a split-mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.
Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the upper arch two groups were identified; group 1 having the extraction space closed using the same working archwire throughout 3 visits after insertion, and group 2 with the working archwire changed monthly.
The working archwire in the upper arch was split into 2 halves in the midline and each one half was connected to the other by a wide joining hook. Patients were followed-up monthly for three months. At every follow up visit upper alginate impressions were taken and the working archwire in the upper arch was changed on one side only. Upper follow-up models were scanned using digital scanner and spaces were measured using digital software.
Three unstimulated saliva samples were collected from each patient; prior to commencement of treatment, when 0.019X0.25-inch SS archwire was reached and before space closure and one month after space closure.
The rate of extraction space closure in the upper arch, ion concentration in saliva samples measured using inductively coupled plasma mass spectrometer (ICP-MS) and frictional resistance of the working archwires was measured using universal mechanical testing machine.
- Conditions
- Orthodontic Appliance
- Being tested
- Space closure without changing working archwire monthly, Space closure withchanging working archwire monthly
- Keywords
- Tooth movement, Friction, Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space closure without changing working archwire monthlyDevice
Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month
Space closure withchanging working archwire monthlyDevice
Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month
| Study group | Role | What they receive |
|---|---|---|
| Without changing working archwire | Experimental | Extraction space closed using the same working archwire throughout 3 visits after insertion Receives: Device: Space closure without changing working archwire monthly |
| With changing working archwire | Experimental | The extraction space closed having the working archwire changed monthly. Receives: Device: Space closure withchanging working archwire monthly |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of space closure per month
the width of upper extraction space in milimeters
Measured: 3 months
Secondary outcomes (2)
ion concentration in saliva
Concentration of ions (Chrome, Iron, Nickel, titanium) in saliva
Measured: through study completion, an average of 1 year
Frictional resistance
A mean value in N for frictional force over a 3 millimeter distance.
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Dec 2018
- Primary completion1 Sep 2019
- Study completion31 Aug 2020
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
- Working archwire status
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 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 S A Alhaija, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549987
- Sponsor's protocol ID
- 53/2019
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 22 Sep 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 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speed of Premolar Extraction Space Closure: The Effect of Every Visit Replacement of Working Arch Wire - A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04549987
- Acronym / sponsor ID
- 53/2019
- Conditions
- Orthodontic Appliance
- Keywords
- Tooth movement, Friction, Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 16 Sep 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.
The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure.
Detailed description
The aims were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro and to assess its effect on rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure and to compare the rate of teeth movement into fresh and old extraction sites.
Trial design: Randomized controlled clinical trial with a split-mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.
Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the upper arch two groups were identified; group 1 having the extraction space closed using the same working archwire throughout 3 visits after insertion, and group 2 with the working archwire changed monthly.
The working archwire in the upper arch was split into 2 halves in the midline and each one half was connected to the other by a wide joining hook. Patients were followed-up monthly for three months. At every follow up visit upper alginate impressions were taken and the working archwire in the upper arch was changed on one side only. Upper follow-up models were scanned using digital scanner and spaces were measured using digital software.
Three unstimulated saliva samples were collected from each patient; prior to commencement of treatment, when 0.019X0.25-inch SS archwire was reached and before space closure and one month after space closure.
The rate of extraction space closure in the upper arch, ion concentration in saliva samples measured using inductively coupled plasma mass spectrometer (ICP-MS) and frictional resistance of the working archwires was measured using universal mechanical testing machine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Working archwire status
| Arm | Type | Receives |
|---|---|---|
| Without changing working archwire | Experimental | Device: Space closure without changing working archwire monthlyExtraction space closed using the same working archwire throughout 3 visits after insertion |
| With changing working archwire | Experimental | Device: Space closure withchanging working archwire monthlyThe extraction space closed having the working archwire changed monthly. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age ≥ 16 years
- Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o)
- Mild upper and lower arch crowding (<4mm) or no crowding
- Need for upper and lower first premolars extraction
- Skeletal I malocclusion (1<ANB <5)
Key exclusion criteria (6 listed)
- Poor oral hygiene
- Diseases and medications that were likely to affect bone biology
- Previous orthodontic treatment
- Evidence of bone loss
- Active periodontal disease
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 |
|---|---|---|
| Space closure without changing working archwire monthlyUpper premolar space closure using the same 0.019X0.025 stainless steel archwire every month | Device | Without changing working archwire |
| Space closure withchanging working archwire monthlyUpper premolar space closure using new 0.019X0.025 stainless steel archwire every month | Device | With changing working archwire |
Primary outcome
The amount of space closure per month
Time frame: 3 months
the width of upper extraction space in milimeters
2 secondary outcomes
ion concentration in saliva
Time frame: through study completion, an average of 1 year
Frictional resistance
Time frame: At the end of the study
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 22 Sep 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 S A 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 Space closure without changing working archwire monthly and Space closure withchanging working archwire monthly 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 8 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 22 Sep 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?
The amount of space closure per month (time frame: 3 months). 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 22 Sep 2020.