Teeth; Anomaly, PositionNCT04090931
A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials
A study testing Orthodontic treatment in people with Teeth; Anomaly, Position, run by University of Baghdad at 1 site in Iraq.
Trial summary
The aim of this study is to compare the effectiveness of using heat-activated NiTi with superelastic NiTi archwires during the initial phase of orthodontic treatment. Primary Objective: To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Teeth; Anomaly, Position
- What is being tested?
- Orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIraq
- Study dates
- 3 Jan 2019to 9 Sep 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII).
- Full set of lower permanent dentition excluding the third molars.
- No history of trauma or root resorption in the lower incisors.
Who cannot join
- Previous orthodontic treatment.
- Less than 3mm of lower incisor crowding (LII) or with spaced incisors.
- Severe crowding in the lower arch (greater than 7mm) which requires extraction.
- Blocked-out teeth that cannot be engaged with the aligning archwire.
- Patients with periodontally compromised teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials: A Randomized Clinical Trial
The aim of this study is to compare the effectiveness of using heat-activated NiTi with superelastic NiTi archwires during the initial phase of orthodontic treatment.
Primary Objective:
To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment.
Secondary Objectives:
- To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular central incisors between the two groups of archwires
- To compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.
Read the detailed description
Objectives: To compare the heat-activated nickel titanium (HANT) with superelastic nickel titanium (SENT) archwires in terms of their effectiveness in aligning teeth, possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.
Subjects and Methods: Orthodontic patient aged 12 years or over with lower anterior crowding of 3-6 mm. who need treatment without extraction, were randomly allocated to the HANT and SENT archwires groups with a 1:1 allocation ratio. Archwire sequence in both groups was 0.014-inch and 0.016-inch, respectively. Each archwire was placed for 4 weeks. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment was tested using 2X2 mixed factorial ANOVA, while root resorption and pain perception were tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).
- Conditions
- Teeth; Anomaly, Position
- Being tested
- Orthodontic treatment
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic treatmentProcedure or surgery
leveling and aligning stage in orthodontics
| Study group | Role | What they receive |
|---|---|---|
| Heat-Activated Nickel-Titanium Archwires | Experimental | Heat-activated NiTi (HANT) Group (TruFlex™ Thermal Nickel-Titanium, Ortho Technology, USA):
* 0.014-inch HANT
* 0.016-inch HANT Receives: Procedure: Orthodontic treatment |
| Superelastic Nickel-Titanium Archwires | Experimental | Superelastic NiTi (SENT) Group (TruFlex™ Nickel-Titanium, Ortho Technology, USA):
* 0.014-inch SENT
* 0.016-inch SENT Receives: Procedure: Orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome (Alignment efficiency)
The study models, which should be free from any inconsistency (such as bubbles), were used to measure the Little's irregularity index (Little, 1975). This was calculated using a digital Vernier caliper to measure the extent of mesial and distal contact displacement from the mesial contact point of lower canine to that on the other side (to the nearest 0.01mm).
Measured: 2 months
Secondary outcomes (2)
Root resorption
Root resorption was evaluated pre-treatment and after 8 weeks using periapical X-ray with digital X-ray sensors (ATECO). Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds.
Measured: 2 months
Pain perception
Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10-point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start3 Jan 2019
- Primary completion26 Apr 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teeth; Anomaly, PositionStudies 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
- Orthodontic patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassir A. Yassir, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090931
- Sponsor's protocol ID
- University of Baghdad
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Materials, Methods, Results
Publications
Nabbat SA, Yassir YA. A clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials: a multicentre randomized clinical trial. Eur J Orthod. 2020 Dec 2;42(6):626-634. doi: 10.1093/ejo/cjz102.
PubMed 32011678
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04090931
- Acronym / sponsor ID
- University of Baghdad
- Conditions
- Teeth; Anomaly, Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 16 Sep 2019 (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 aim of this study is to compare the effectiveness of using heat-activated NiTi with superelastic NiTi archwires during the initial phase of orthodontic treatment.
Primary Objective:
To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment.
Secondary Objectives:
- To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular central incisors between the two groups of archwires
- To compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.
Detailed description
Objectives: To compare the heat-activated nickel titanium (HANT) with superelastic nickel titanium (SENT) archwires in terms of their effectiveness in aligning teeth, possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.
Subjects and Methods: Orthodontic patient aged 12 years or over with lower anterior crowding of 3-6 mm. who need treatment without extraction, were randomly allocated to the HANT and SENT archwires groups with a 1:1 allocation ratio. Archwire sequence in both groups was 0.014-inch and 0.016-inch, respectively. Each archwire was placed for 4 weeks. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment was tested using 2X2 mixed factorial ANOVA, while root resorption and pain perception were tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Orthodontic patients
| Arm | Type | Receives |
|---|---|---|
| Heat-Activated Nickel-Titanium Archwires | Experimental | Procedure: Orthodontic treatmentHeat-activated NiTi (HANT) Group (TruFlex™ Thermal Nickel-Titanium, Ortho Technology, USA): * 0.014-inch HANT * 0.016-inch HANT |
| Superelastic Nickel-Titanium Archwires | Experimental | Procedure: Orthodontic treatmentSuperelastic NiTi (SENT) Group (TruFlex™ Nickel-Titanium, Ortho Technology, USA): * 0.014-inch SENT * 0.016-inch SENT |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII).
- Full set of lower permanent dentition excluding the third molars.
- No history of trauma or root resorption in the lower incisors.
Key exclusion criteria (5 listed)
- Previous orthodontic treatment.
- Less than 3mm of lower incisor crowding (LII) or with spaced incisors.
- Severe crowding in the lower arch (greater than 7mm) which requires extraction.
- Blocked-out teeth that cannot be engaged with the aligning archwire.
- Patients with periodontally compromised teeth.
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 |
|---|---|---|
| Orthodontic treatmentleveling and aligning stage in orthodontics | Procedure or surgery | Heat-Activated Nickel-Titanium Archwires, Superelastic Nickel-Titanium Archwires |
Primary outcome
Primary outcome (Alignment efficiency)
Time frame: 2 months
The study models, which should be free from any inconsistency (such as bubbles), were used to measure the Little's irregularity index (Little, 1975). This was calculated using a digital Vernier caliper to measure the extent of mesial and distal contact displacement from the mesial contact point of lower canine to that on the other side (to the nearest 0.01mm).
2 secondary outcomes
Root resorption
Time frame: 2 months
Pain perception
Time frame: 2 months
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 18 Sep 2019.
- Derived from this study: PubMed 32011678Nabbat SA, Yassir YA. A clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials: a multicentre randomized clinical trial. Eur J Orthod. 2020 Dec 2;42(6):626-634. doi: 10.1093/ejo/cjz102.
- Individual participant dataSharing planned: No. Materials, Methods, Results
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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 Orthodontic treatment in people with Teeth; Anomaly, Position, 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 3 inclusion and 5 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 18 Sep 2019. 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?
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?
Primary outcome (Alignment efficiency) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04090931, which also lists 1 linked publication.
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 18 Sep 2019.