Crowding of Anterior Mandibular TeethNCT05676840
Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires
A study testing orthodontic treatment with fixed appliances in people with Crowding of Anterior Mandibular Teeth, run by Ziauddin University at 1 site in Pakistan.
Trial summary
To compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- orthodontic treatment with fixed appliances
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to Jun 2024
- 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
- lower anterior crowding good oral hygeine all permanent lower incisors no previous orthodontic treatment
Who cannot join
- extracted or missing lower incisors poor oral hygeine relevant medical history previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires. A Randomized Control Trial
To compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires.
Read the detailed description
Method: All the participants will be recruited from Ziauddin University dental OPD, each will be provided with full information about study. An informed consent form will be signed from every patient or their guardian/parents. Patients who agree to be part of this study will be included.
Subjects will be treated by Orthodontic resident under faculty supervision. Pre-treatment mandibular crowding will be assessed on dental casts. Randomization of the three groups will be done by "Opaque envelope technique" Bonding will be done using 3M uniteck brackets. After initial bonding good quality mandibular impressions will be taken and poured to obtain dental casts. Impressions and casts will be obtained at every 4 weeks interval until the initial alignment phase is complete. At the time of bonding all lower anterior teeth will be fully engaged in the archwire. The principal researcher will tag every model with an identification code before calculating measurements.
The contact point displacements will be measured with vernier caliper using the Little's index of irregularity. All measurements will be then summed and aggregated value will represent the degree of anterior irregularities.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- orthodontic treatment with fixed appliances
- Keywords
- Nickel Titanium, Archwires, Crowding, Alignment, Nitinol
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic treatment with fixed appliancesProcedure or surgery
comprehensive orthodontic treatment with fixed orthodontic appliances for the correction of misaligned teeth.
| Study group | Role | What they receive |
|---|---|---|
| conventional niti arch wire group | Other | all participants in this group will be placed conventional 014 niti lower archwire. Receives: Procedure: orthodontic treatment with fixed appliances |
| super elastic niti archwire group | Other | all participants will be given super elastic 014 lower NiTi archwire. Receives: Procedure: orthodontic treatment with fixed appliances |
| thermal niti archwire group | Other | all participants will be given thermal lower 014 niti archwire. Receives: Procedure: orthodontic treatment with fixed appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the alignment efficiency of three types of NiTi archwires.
alignment of lower anterior crowding
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 May 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Model description
- three groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676840
- Sponsor's protocol ID
- 1431019DSAOM
- Status last verified
- Apr 2023
- First submitted
- 22 Dec 2022
- Last updated
- 21 Apr 2023
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05676840
- Acronym / sponsor ID
- 1431019DSAOM
- Conditions
- Crowding of Anterior Mandibular Teeth
- Keywords
- Nickel Titanium, Archwires, Crowding, Alignment, Nitinol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Jan 2023 (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 compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires.
Detailed description
Method: All the participants will be recruited from Ziauddin University dental OPD, each will be provided with full information about study. An informed consent form will be signed from every patient or their guardian/parents. Patients who agree to be part of this study will be included.
Subjects will be treated by Orthodontic resident under faculty supervision. Pre-treatment mandibular crowding will be assessed on dental casts. Randomization of the three groups will be done by "Opaque envelope technique" Bonding will be done using 3M uniteck brackets. After initial bonding good quality mandibular impressions will be taken and poured to obtain dental casts. Impressions and casts will be obtained at every 4 weeks interval until the initial alignment phase is complete. At the time of bonding all lower anterior teeth will be fully engaged in the archwire. The principal researcher will tag every model with an identification code before calculating measurements.
The contact point displacements will be measured with vernier caliper using the Little's index of irregularity. All measurements will be then summed and aggregated value will represent the degree of anterior irregularities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three groups
| Arm | Type | Receives |
|---|---|---|
| conventional niti arch wire group | Other | Procedure: orthodontic treatment with fixed appliancesall participants in this group will be placed conventional 014 niti lower archwire. |
| super elastic niti archwire group | Other | Procedure: orthodontic treatment with fixed appliancesall participants will be given super elastic 014 lower NiTi archwire. |
| thermal niti archwire group | Other | Procedure: orthodontic treatment with fixed appliancesall participants will be given thermal lower 014 niti archwire. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- lower anterior crowding good oral hygeine all permanent lower incisors no previous orthodontic treatment
Key exclusion criteria (1 listed)
- extracted or missing lower incisors poor oral hygeine relevant medical history previous orthodontic treatment
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 treatment with fixed appliancescomprehensive orthodontic treatment with fixed orthodontic appliances for the correction of misaligned teeth. | Procedure or surgery | conventional niti arch wire group, super elastic niti archwire group, thermal niti archwire group |
Primary outcome
comparing the alignment efficiency of three types of NiTi archwires.
Time frame: 4 months
alignment of lower anterior crowding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
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Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
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Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
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Active, not recruiting
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
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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 with fixed appliances in people with Crowding of Anterior Mandibular Teeth, run by Ziauddin University at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 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 Pakistan. 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?
Results are not available in the source record.
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?
comparing the alignment efficiency of three types of NiTi archwires. (time frame: 4 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 21 Apr 2023.