Crowding of Anterior Mandibular TeethNCT05510206
SmartArch vs Super Elastic NiTi Aligning Archwires
A study testing Leveling and alignment in people with Crowding of Anterior Mandibular Teeth, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study is intended primarily to compare the alignment efficiency and rate of two different types of archwires that are used in the first stage of orthodontic treatment , also addressing pain and root resorption that may be associated during treatment, with the hypothesis being a consideration of no deference… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- Leveling and alignment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 17 Apr 2022to 14 Dec 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII).
- Presence of all mandibular permanent teeth, except the third molars.
- Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
- No history of trauma or root resorption in the mandibular incisors.
Who cannot join
- Previous orthodontic treatment.
- Less than 5mm of mandibular incisor crowding (LII).
- Blocked-out teeth that cannot be engaged with the aligning archwire.
- Prior experience of periodontal disease and loss of attachment.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
University of Baghdad\ College of Dentistry
Baghdad, Bab Al-Moadham, 10047
About this study
Official title: The Effectiveness of SmartArch Versus Super Elastic Nickel-titanium Aligning Archwires: a Randomized Clinical Trial
This study is intended primarily to compare the alignment efficiency and rate of two different types of archwires that are used in the first stage of orthodontic treatment , also addressing pain and root resorption that may be associated during treatment, with the hypothesis being a consideration of no deference between the two archwires.
Read the detailed description
This will be a multicenter non-stratified prospective randomized clinical trial with parallel groups trial with equal randomization (1:1 allocation ratio), two public orthodontic center will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. Then they will be provided by the patient information sheet and consent form, which explains the nature of the study, to read carefully at home and provide their decision about participation at the subsequent appointment. If the patient age below 18 years, parent assent should be taken. Any further enquiries regarding the study by the patient should be resolved by the investigator on the second visit.
The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Bracket placement will be standardized using a height gauge. Initially, teeth polishing will be performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique will be standardized as follows:
- Teeth etching with 37% phosphoric acid gel for 30 seconds.
- Rinsing thoroughly (5 seconds per tooth for liquid etchant and 10 seconds per tooth for gel etchant) to stop the etching process and to remove demineralized particles then air drying until the white frosty appearance of the etched surface is observed.
- Application of a thin layer of Light Bond™ Sealant (Reliance®, Itasca, USA) for one minute and air application for 5 seconds.
- Bonding of brackets and tubes using Light Bond™ light cure orthodontic adhesive (Reliance®, Itasca, USA) applied on their bases and light-cured above interproximal contacts at a distance of 2-3 mm (5 seconds mesially and 5 seconds distally for brackets and 10 seconds mesially and 10 seconds occlusally for molar tubes).
All the participants will receive a standardized treatment protocol. At the day of bonding, 0.016-inch archwire will be placed for the Smartarch group. It will be re-ligated every four weeks. While, for the super elastic NiTi group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules, with laceback of canines to first molars. If there is any debonding during treatment, this should be dealt with as an emergency case and re-bonded within 24 hours, otherwise the case will be considered as dropout. Since this study will be performed during the initial phase of treatment, no deviation in the protocol of treatment will be accepted (such as adding additional archwire in the sequence or using power chain). A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- Leveling and alignment
- Keywords
- lower anterior crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leveling and alignmentDevice
Polishing, Bonding of appliance, placement of the first arch wire for Super elastic NiTi group then the second wire after two months taking study model each month during the study For Smartarch Group placing experimental arch wire for 4 months , taking impression each month.
For both groups peri-apical X-Ray to lower anterior teeth is taken prior to treatment and 4 months later, also visual pain analogue scale is taken for 7 days after placing archwires
| Study group | Role | What they receive |
|---|---|---|
| Super elastic NiTi Group | Active comparator | 0.014-inch super elastic nickel-titanium archwire (ortho Technology™ , west Columbia, USA) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Receives: Device: Leveling and alignment |
| Smartarch Group | Experimental | 0.016-inch Smartarch archwir (Ormco™, USA) will be placed in mandibular arch at the day of bonding. Re-ligated every four weeks for 16 weeks. Receives: Device: Leveling and alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alignment of anterior teeth will be measured using Little's irregularity index
A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. This study model which should be free from any discrepancy (such as bubbles) will be used to measure Little's irregularity index using a digital Vernier caliper to calculate the amount of mesial and distal contact displacement from the mesial contact surface of right mandibular canine to that on the other side, to the nearest 0.01 mm. The sum of these measurements represents the amount of Little's irregularity index.
Measured: 16 weeks
Secondary outcomes (2)
Root resorption incidence using the scoring index that was provided by Malmgren et al. (1982)
assessed by scoring system for orthodontic induced apical root resorption from (0-3) on Root resorption will be evaluated for the mandibular central incisors using periapical radiographs with digital sensors, and the worst score for either left or right central will be taken using the scoring index by Malmgren et al. (1982):
Grade 1: Irregular apical root contour. Grade 2: Minor apical root resorption, a small area of root loss amounting to less than 2 mm.
Grade 3: Severe apical root resorption from 2 mm to one third of the original root length.
Grade 4: Extreme apical root resorption exceeding one third of the original root length.
Measured: 16 weeks
Pain perception using visual analog scale
Evaluations of pain/discomfort will be made in the evening on a daily basis over the first seven days after bonding using a 10-point visual analog scale (VAS) with 0 refers to "no pain" and 10 refers to "intolerable pain". The participants will be reminded daily by a phone call or a text message to mark the recording sheet and will be asked to bring it on their next appointment.
Measured: 1st week after wire placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start17 Apr 2022
- Primary completion24 Aug 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crowding of Anterior Mandibular TeethStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Khairullah Ahmed, University of Baghdad
- Investigators
- Ammar S. Kadhum, Asst. Prof., Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510206
- Sponsor's protocol ID
- 611422
- Status last verified
- May 2023
- First submitted
- 2 Aug 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available on request.
Publications
Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.
PubMed 6961819Nabbat 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 32011678Wang Y, Liu C, Jian F, McIntyre GT, Millett DT, Hickman J, Lai W. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD007859. doi: 10.1002/14651858.CD007859.pub4.
PubMed 30064155Noori RM, Ahmed OK, Kadhum AS, Yassir YA, Di Blasio M, Russo D, Cicciu M, Minervini G. The Effectiveness of Conventional and Advanced Aligning Archwires: The Insights of Two Randomized Clinical Trials. Eur J Dent. 2025 Oct;19(4):985-997. doi: 10.1055/s-0044-1795080. Epub 2025 Apr 4.
PubMed 40185146
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of SmartArch Versus Super Elastic Nickel-titanium Aligning Archwires: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05510206
- Acronym / sponsor ID
- 611422
- Conditions
- Crowding of Anterior Mandibular Teeth
- Keywords
- lower anterior crowding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 22 Aug 2022 (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.
This study is intended primarily to compare the alignment efficiency and rate of two different types of archwires that are used in the first stage of orthodontic treatment , also addressing pain and root resorption that may be associated during treatment, with the hypothesis being a consideration of no deference between the two archwires.
Detailed description
This will be a multicenter non-stratified prospective randomized clinical trial with parallel groups trial with equal randomization (1:1 allocation ratio), two public orthodontic center will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. Then they will be provided by the patient information sheet and consent form, which explains the nature of the study, to read carefully at home and provide their decision about participation at the subsequent appointment. If the patient age below 18 years, parent assent should be taken. Any further enquiries regarding the study by the patient should be resolved by the investigator on the second visit.
The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Bracket placement will be standardized using a height gauge. Initially, teeth polishing will be performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique will be standardized as follows:
- Teeth etching with 37% phosphoric acid gel for 30 seconds.
- Rinsing thoroughly (5 seconds per tooth for liquid etchant and 10 seconds per tooth for gel etchant) to stop the etching process and to remove demineralized particles then air drying until the white frosty appearance of the etched surface is observed.
- Application of a thin layer of Light Bond™ Sealant (Reliance®, Itasca, USA) for one minute and air application for 5 seconds.
- Bonding of brackets and tubes using Light Bond™ light cure orthodontic adhesive (Reliance®, Itasca, USA) applied on their bases and light-cured above interproximal contacts at a distance of 2-3 mm (5 seconds mesially and 5 seconds distally for brackets and 10 seconds mesially and 10 seconds occlusally for molar tubes).
All the participants will receive a standardized treatment protocol. At the day of bonding, 0.016-inch archwire will be placed for the Smartarch group. It will be re-ligated every four weeks. While, for the super elastic NiTi group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules, with laceback of canines to first molars. If there is any debonding during treatment, this should be dealt with as an emergency case and re-bonded within 24 hours, otherwise the case will be considered as dropout. Since this study will be performed during the initial phase of treatment, no deviation in the protocol of treatment will be accepted (such as adding additional archwire in the sequence or using power chain). A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super elastic NiTi Group | Active comparator | Device: Leveling and alignment0.014-inch super elastic nickel-titanium archwire (ortho Technology™ , west Columbia, USA) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. |
| Smartarch Group | Experimental | Device: Leveling and alignment0.016-inch Smartarch archwir (Ormco™, USA) will be placed in mandibular arch at the day of bonding. Re-ligated every four weeks for 16 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII).
- Presence of all mandibular permanent teeth, except the third molars.
- Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
- No history of trauma or root resorption in the mandibular incisors.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment.
- Less than 5mm of mandibular incisor crowding (LII).
- Blocked-out teeth that cannot be engaged with the aligning archwire.
- Prior experience of periodontal disease and loss of attachment.
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 |
|---|---|---|
| Leveling and alignmentPolishing, Bonding of appliance, placement of the first arch wire for Super elastic NiTi group then the second wire after two months taking study model each month during the study For Smartarch Group placing experimental arch wire for 4 months , taking impression each month. For both groups peri-apical X-Ray to lower anterior teeth is taken prior to treatment and 4 months later, also visual pain analogue scale is taken for 7 days after placing archwires | Device | Smartarch Group, Super elastic NiTi Group |
Primary outcome
Changes in alignment of anterior teeth will be measured using Little's irregularity index
Time frame: 16 weeks
A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. This study model which should be free from any discrepancy (such as bubbles) will be used to measure Little's irregularity index using a digital Vernier caliper to calculate the amount of mesial and distal contact displacement from the mesial contact surface of right mandibular canine to that on the other side, to the nearest 0.01 mm. The sum of these measurements represents the amount of Little's irregularity index.
2 secondary outcomes
Root resorption incidence using the scoring index that was provided by Malmgren et al. (1982)
Time frame: 16 weeks
Pain perception using visual analog scale
Time frame: 1st week after wire placement
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 11 May 2023.
- Background: PubMed 6961819Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.
- Background: 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.
- Background: PubMed 30064155Wang Y, Liu C, Jian F, McIntyre GT, Millett DT, Hickman J, Lai W. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD007859. doi: 10.1002/14651858.CD007859.pub4.
- Derived from this study: PubMed 40185146Noori RM, Ahmed OK, Kadhum AS, Yassir YA, Di Blasio M, Russo D, Cicciu M, Minervini G. The Effectiveness of Conventional and Advanced Aligning Archwires: The Insights of Two Randomized Clinical Trials. Eur J Dent. 2025 Oct;19(4):985-997. doi: 10.1055/s-0044-1795080. Epub 2025 Apr 4.
- Individual participant dataSharing planned: Yes. It will be available on request.
Related trials for Crowding of Anterior Mandibular Teeth
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
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.
Ammar S. Kadhum, Asst. Prof. study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leveling and alignment in people with Crowding of Anterior Mandibular Teeth, 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 4 inclusion and 4 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 11 May 2023. 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?
Changes in alignment of anterior teeth will be measured using Little's irregularity index (time frame: 16 weeks). 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 NCT05510206, which also lists 4 linked publications.
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 11 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.