Dental MalocclusionNCT04387578
Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling
A study testing fixed orthodontic appliance and arch wires in people with Dental Malocclusion and Dental Crowding, run by Ahmed Talaat Hussein Ali at 1 site in Egypt.
Trial summary
The present prospective clinical study was directed to evaluate the efficiency of three different aligning archwires during initial orthodontic leveling. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Dental Malocclusion, Dental Crowding
- What is being tested?
- fixed orthodontic appliance and arch wires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 20 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 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An age range from 15 to 20 years
- All permanent teeth have erupted (3rd molar not included)
- Angle class I malocclusion with normal facial proportions.
- Moderate crowding in the lower dental arch that required treatment with fixed appliance using the non-extraction approach.
- Good oral hygiene with healthy periodontium, good general health without any systematic disease that could affect the treatment.
Who cannot join
- Severe crowding that requires an extraction approach.
- A blocked-out tooth that prevent the easy placement of the bracket at the initial bonding appointment.
- Poor oral hygiene or periodontal compromised teeth.
- Relevant medical history and/or regular medication that contraindicates and/or interferes with orthodontic treatment.
- Craniofacial anomalies or previous history of trauma, bruxism, or parafunction.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling: A Prospective Clinical Study
The present prospective clinical study was directed to evaluate the efficiency of three different aligning archwires during initial orthodontic leveling.
Read the detailed description
The present prospective clinical study was directed to evaluate efficiency of three different aligning arch wires during initial orthodontic leveling.
The sample of present study included 30 patients, 15 females and 15 males; with a mean age was 17.81 ± 1.96 years. They were randomly allocated into three equal groups, according to the type of the aligning arch wire as follows:
- Group A: in which 10 patients, with a mean age was 17.27 ± 1.95 years, were treated with conventional singlestrand NiTi arch wires.
- Group B: in which 10 patients, with a mean age was 17.33 ± 2.42 years, were treated with Niobium-titanium-tantalum-Zirconium (Gummetal) arch wires.
- Group C: in which 10 patients, with a mean age was 18.70 ± 1.49 years, were treated with multistrand NiTi arch wires.
Mandibular orthodontic study models were taken every 4 weeks and laser scanned to obtain 3D digital models during the 3 months observation period of the study. The changes in LII were determined at every 4 weeks observation intervals. Moreover, the changes in inter-canine, inter-1st premolar and inter-molar widths before and after three months were evaluated and compared among the three groups of aligning arch wires.
Data were collected and statistically analyzed via Statistical Package for Social Science (SPSS, version 23). One Way ANOVA and Kruskall-Wallis tests were used to assess the difference among the three studied groups and paired t-test was used to assess the difference and percent of changes within each group before and after three months observation period.
- Conditions
- Dental Malocclusion, Dental Crowding
- Being tested
- fixed orthodontic appliance and arch wires
- Keywords
- Orthodontic arch wire, alignment, Gummetal arch wire, multistrand arch wire
- Medical subject headings
- Malocclusion, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed orthodontic appliance and arch wiresDevice
leveling and aligning stages in orthodontics
| Study group | Role | What they receive |
|---|---|---|
| Group A singlestrand NiTi arch wires | Experimental | in which 10 patients (5 males and 5 females) were treated with round singlestrand NiTi arch wires in a sequence of 0.012, 0.014, and 0.016 inch. Receives: Device: fixed orthodontic appliance and arch wires |
| Group B Gummetal arch wires | Experimental | in which 10patients (6 males and 4 females) were treated with niobium-titanium-tantalum-Zirconium arch wires (Gummetal arch wires) in a sequence of 0.014, 0.016, and 0.018 inch. Receives: Device: fixed orthodontic appliance and arch wires |
| Group C multistrand NiTi arch wires | Experimental | in which 10 patients (4males and 6females) were treated with multistrand NiTi arch wires in a sequence of 0.016, 0.018, and 0.020 inch. Receives: Device: fixed orthodontic appliance and arch wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the alignment efficiency
evaluation of the alignment efficiency among the three investigated arch wires via the measurement of the scores of Little's Irregularity Index
Measured: three months of leveling and alignment
comparison of the alignment efficiency
comparison of the alignment efficiency among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Measured: three months of leveling and alignment
evaluation of the alignment rate
evaluation of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Measured: three months of leveling and alignment
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Measured: three months of leveling and alignment
Secondary outcomes (2)
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Measured: three months of leveling and alignment
comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.
comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Measured: three months of leveling and alignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Sep 2018
- Primary completion10 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies 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
- Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Talaat Hussein Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Talaat Hussein Ali, Al-Azhar University
- Investigators
- Ahmed T Ali, Demonstrator, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387578
- Sponsor's protocol ID
- 103
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04387578
- Acronym / sponsor ID
- 103
- Conditions
- Dental Malocclusion, Dental Crowding
- Keywords
- Orthodontic arch wire, alignment, Gummetal arch wire, multistrand arch wire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahmed Talaat Hussein AliUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 14 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.
The present prospective clinical study was directed to evaluate the efficiency of three different aligning archwires during initial orthodontic leveling.
Detailed description
The present prospective clinical study was directed to evaluate efficiency of three different aligning arch wires during initial orthodontic leveling.
The sample of present study included 30 patients, 15 females and 15 males; with a mean age was 17.81 ± 1.96 years. They were randomly allocated into three equal groups, according to the type of the aligning arch wire as follows:
- Group A: in which 10 patients, with a mean age was 17.27 ± 1.95 years, were treated with conventional singlestrand NiTi arch wires.
- Group B: in which 10 patients, with a mean age was 17.33 ± 2.42 years, were treated with Niobium-titanium-tantalum-Zirconium (Gummetal) arch wires.
- Group C: in which 10 patients, with a mean age was 18.70 ± 1.49 years, were treated with multistrand NiTi arch wires.
Mandibular orthodontic study models were taken every 4 weeks and laser scanned to obtain 3D digital models during the 3 months observation period of the study. The changes in LII were determined at every 4 weeks observation intervals. Moreover, the changes in inter-canine, inter-1st premolar and inter-molar widths before and after three months were evaluated and compared among the three groups of aligning arch wires.
Data were collected and statistically analyzed via Statistical Package for Social Science (SPSS, version 23). One Way ANOVA and Kruskall-Wallis tests were used to assess the difference among the three studied groups and paired t-test was used to assess the difference and percent of changes within each group before and after three months observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Group A singlestrand NiTi arch wires | Experimental | Device: fixed orthodontic appliance and arch wiresin which 10 patients (5 males and 5 females) were treated with round singlestrand NiTi arch wires in a sequence of 0.012, 0.014, and 0.016 inch. |
| Group B Gummetal arch wires | Experimental | Device: fixed orthodontic appliance and arch wiresin which 10patients (6 males and 4 females) were treated with niobium-titanium-tantalum-Zirconium arch wires (Gummetal arch wires) in a sequence of 0.014, 0.016, and 0.018 inch. |
| Group C multistrand NiTi arch wires | Experimental | Device: fixed orthodontic appliance and arch wiresin which 10 patients (4males and 6females) were treated with multistrand NiTi arch wires in a sequence of 0.016, 0.018, and 0.020 inch. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- An age range from 15 to 20 years
- All permanent teeth have erupted (3rd molar not included)
- Angle class I malocclusion with normal facial proportions.
- Moderate crowding in the lower dental arch that required treatment with fixed appliance using the non-extraction approach.
- Good oral hygiene with healthy periodontium, good general health without any systematic disease that could affect the treatment.
Key exclusion criteria (6 listed)
- Severe crowding that requires an extraction approach.
- A blocked-out tooth that prevent the easy placement of the bracket at the initial bonding appointment.
- Poor oral hygiene or periodontal compromised teeth.
- Relevant medical history and/or regular medication that contraindicates and/or interferes with orthodontic treatment.
- Craniofacial anomalies or previous history of trauma, bruxism, or parafunction.
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 |
|---|---|---|
| fixed orthodontic appliance and arch wiresleveling and aligning stages in orthodontics | Device | Group A singlestrand NiTi arch wires, Group B Gummetal arch wires, Group C multistrand NiTi arch wires |
Primary outcome
evaluation of the alignment efficiency
Time frame: three months of leveling and alignment
evaluation of the alignment efficiency among the three investigated arch wires via the measurement of the scores of Little's Irregularity Index
comparison of the alignment efficiency
Time frame: three months of leveling and alignment
comparison of the alignment efficiency among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
evaluation of the alignment rate
Time frame: three months of leveling and alignment
evaluation of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Time frame: three months of leveling and alignment
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
2 secondary outcomes
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Time frame: three months of leveling and alignment
comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Time frame: three months of leveling and alignment
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 14 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.
Ahmed T Ali, Demonstrator principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixed orthodontic appliance and arch wires in people with Dental Malocclusion and Dental Crowding, run by Ahmed Talaat Hussein Ali at 1 site in Egypt.
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 14 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 Egypt. 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?
evaluation of the alignment efficiency (time frame: three months of leveling and alignment). The study lists 4 primary outcomes in all. 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 14 May 2020.