AlignmentAlignmentNCT07733258
Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases.
A study testing Separating phases of alignment and leveling using heat activated niti archwire in people with Alignment and Leveling and Alignment of Teeth, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Study Summary The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alignment, Leveling and Alignment of Teeth
- What is being tested?
- Separating phases of alignment and leveling using heat activated niti archwire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2023to 8 Oct 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-30 years age
- Skeletal Class 1
- Angle class 1 malocclusion
- Little's irregularity index falls between 4-8mm
- Curve of spee depth 3-4mm
- Non-extraction Orthodontic plan
Who cannot join
- Previous Orthodontic treatment
- Advanced periodontal problem
- Drug used that modify bone metabolism
- Growing patients
- Patient with anterior mandibular spacing
- Systemic Disease (uncontrolled diabetes Mellitus etc )
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
Karachi, Sindh, 75300
About this study
Official title: Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases During Fixed Orthodontic Treatment: A Randomized Clinical Trial
Study Summary
The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment.
Read the detailed description
Study Summary
The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment.
The main questions it aims to answer are:
Does separating the aligning and leveling phases result in better control of mandibular incisor inclination compared with the conventional simultaneous approach? Does the modified treatment approach reduce unwanted proclination of mandibular incisors during the initial phase of orthodontic treatment?
Researchers will compare patients treated with a separated aligning and leveling protocol to those treated with the conventional simultaneous aligning and leveling protocol to determine whether the modified approach provides superior control of mandibular incisor inclination.
Participants will:
Undergo a clinical examination and baseline orthodontic records, including dental casts and lateral cephalometric radiographs.
Be randomly assigned to either the experimental (separated aligning and leveling) group or the conventional treatment group.
Receive fixed orthodontic treatment according to the allocated treatment protocol.
Attend regular follow-up appointments for archwire changes and treatment monitoring.
Undergo post-treatment assessment of mandibular incisor inclination and other relevant treatment outcomes using lateral cephalometric radiographs.
- Conditions
- Alignment, Leveling and Alignment of Teeth
- Being tested
- Separating phases of alignment and leveling using heat activated niti archwire
- Keywords
- alignment, leveling, archwire, fixed orthodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Separating phases of alignment and leveling using heat activated niti archwireOther
6 months
| Study group | Role | What they receive |
|---|---|---|
| separated phases of leveling and alignment | Experimental | Separated phases of leveling and alignment using heat activated niti archwires Receives: Other: Separating phases of alignment and leveling using heat activated niti archwire |
| Combined leveling alignment | No intervention | Combined levelling and alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
to Control mandibular incisor inclination
control mandibular incisor inclination using heat activated niti archwire. It will be checked through cephalometric radiographs using the angles: Incisor Mandibular Plane Angle (IMPA) at T0: baseline, T1: 3 months follow up and T2: 6 month follow up.
Measured: 6 months
Secondary outcomes (1)
TO flatten curve of spee
Flattening of curve of spee using heat activated niti archwires. It will be checked at cast by placing a flat object on the occlusal surface and measuring the deepest point from the premolar to the flat surface at T0: baseline, T1: 3 months follow up and T2: 6 month follow up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start10 Oct 2023
- Primary completion10 Aug 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlignmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arm parallel
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sadaf Zehra, Dow University of Health Sciences
- Investigators
- Sadia Rizwan, BDS, FCPS, CHPE, Study director, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733258
- Sponsor's protocol ID
- Dr Sadaf Zehra
- Acronym
- Alignment
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases During Fixed Orthodontic Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07733258
- Acronym / sponsor ID
- Alignment / Dr Sadaf Zehra
- Conditions
- Alignment, Leveling and Alignment of Teeth
- Keywords
- alignment, leveling, archwire, fixed orthodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 29 Jul 2026 (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.
Study Summary
The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment.
Detailed description
Study Summary
The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment.
The main questions it aims to answer are:
Does separating the aligning and leveling phases result in better control of mandibular incisor inclination compared with the conventional simultaneous approach? Does the modified treatment approach reduce unwanted proclination of mandibular incisors during the initial phase of orthodontic treatment?
Researchers will compare patients treated with a separated aligning and leveling protocol to those treated with the conventional simultaneous aligning and leveling protocol to determine whether the modified approach provides superior control of mandibular incisor inclination.
Participants will:
Undergo a clinical examination and baseline orthodontic records, including dental casts and lateral cephalometric radiographs.
Be randomly assigned to either the experimental (separated aligning and leveling) group or the conventional treatment group.
Receive fixed orthodontic treatment according to the allocated treatment protocol.
Attend regular follow-up appointments for archwire changes and treatment monitoring.
Undergo post-treatment assessment of mandibular incisor inclination and other relevant treatment outcomes using lateral cephalometric radiographs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two arm parallel
| Arm | Type | Receives |
|---|---|---|
| separated phases of leveling and alignment | Experimental | Other: Separating phases of alignment and leveling using heat activated niti archwireSeparated phases of leveling and alignment using heat activated niti archwires |
| Combined leveling alignment | No intervention | –Combined levelling and alignment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-30 years age
- Skeletal Class 1
- Angle class 1 malocclusion
- Little's irregularity index falls between 4-8mm
- Curve of spee depth 3-4mm
Key exclusion criteria (6 listed)
- Previous Orthodontic treatment
- Advanced periodontal problem
- Drug used that modify bone metabolism
- Growing patients
- Patient with anterior mandibular spacing
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 |
|---|---|---|
| Separating phases of alignment and leveling using heat activated niti archwire6 months | Other | separated phases of leveling and alignment |
Primary outcome
to Control mandibular incisor inclination
Time frame: 6 months
control mandibular incisor inclination using heat activated niti archwire. It will be checked through cephalometric radiographs using the angles: Incisor Mandibular Plane Angle (IMPA) at T0: baseline, T1: 3 months follow up and T2: 6 month follow up.
1 secondary outcome
TO flatten curve of spee
Time frame: 6 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 29 Jul 2026.
- Separation of aligning and leveling stages to control mandibular incisor inclination: A randomized clinical trialLink provided by the sponsor.
- 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.
Sadia Rizwan, BDS, FCPS, CHPE study director
Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Separating phases of alignment and leveling using heat activated niti archwire in people with Alignment and Leveling and Alignment of Teeth, run by Dow University of Health Sciences 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 6 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 29 Jul 2026. 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?
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?
to Control mandibular incisor inclination (time frame: 6 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 29 Jul 2026.