Speed of AlignmentNCT07758556
Comparison of Alignment Speed, Patient Discomfort and Root Resorption Between Two Different Sequences of Archwires
A study testing Archwire in people with Speed of Alignment and Pain, run by Foundation University Islamabad at 3 sites in Pakistan.
Trial summary
In this Clinical trial we aim to compare alignment speed, patient discomfort and root resorption between two different sequences of NiTi archwires Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Speed of Alignment, Pain, External Root Resorption
- What is being tested?
- Archwire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesPakistan
- Study dates
- 20 Dec 2024to 2 Sep 2025
- 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 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range 12-35 years.
- Both male and female patients.
- Medically-fit patients with no medical condition associated with root resorption risk.
- No previous history of orthodontic treatment.
- Patients requiring complete upper and lower orthodontic treatment with fixed appliance.
- Angle class I, II, and III malocclusion with crowding in both maxillary and mandibular anterior dentition.
- Healthy permanent dentition with adequate oral hygiene and no periodontal diseases; before the start of orthodontic treatment.
Who cannot join
- Cleft lip \& palate patients
- Syndromic patients
- Patients with bone pathologies
- Habits such as smoking
- Patients with parafunctional habits or history of pre-existing root resorption
- Patients taking drugs which inhibit or accelerate tooth movement
Show all 10Show fewer
- Tooth or teeth with periapical infection.
- Patients with pain from any other medical or dental condition that may have affected their reported discomfort scores were excluded
- Endodontically treated mandibular or maxillary anterior teeth
- Presence of blocked-out tooth that did not allow for placement of the bracket or full AW engagement at the initial bonding.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Foundation University Islamabad
Islamabad, Punjab Province, 04403
FUI
Islamabad, Punjab Province, 43000
FUI
Islamabad, Punjab Province, 46000
About this study
In this Clinical trial we aim to compare alignment speed, patient discomfort and root resorption between two different sequences of NiTi archwires
Read the detailed description
This study will establish and evaluate a set of alignment wires that is efficient in terms of reduced number of patient's visits, yet periodontally safe and acceptable in terms of patient discomfort.
- Conditions
- Speed of Alignment, Pain, External Root Resorption
- Being tested
- Archwire
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArchwireDevice
NiTi Archwires will be used for tooth alignment
| Study group | Role | What they receive |
|---|---|---|
| Treatment two archwires | Experimental | Patients undergoing archwire sequence as follows 0.014 inch NiTi 0.019x0.025 inch NiTi Receives: Device: Archwire |
| Treatment with five archwires | Experimental | Patients undergoing archwire sequence as follows 0.014 inch NiTi 0.018 inch NiTi 0.020 inch NiTi 0.016x0.022 inch NiTi 0.019x0.025 inch NiTi Receives: Device: Archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of alignment
Speed of alignment will be calculated in terms of number of visits and measured by Littles irregularity Index in millimeters
Measured: 6 months
Secondary outcomes (1)
Patient discomfort
Will be measured as scoring on pain proforma on Visual analogue scale
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 posted11 Aug 2026
- Study start20 Dec 2024
- Primary completion2 Jul 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speed of AlignmentStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
- Investigators
- Shoaib Rahim, FCPS, Study chair, FUCD & HRozina Nazir, FCPS, Study chair, FUCD & H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758556
- Sponsor's protocol ID
- FUCDCLINIC-2403
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alignment Speed, Patient Discomfort and Root Resorption Between Two Different Sequences of Archwires
- ClinicalTrials.gov ID
- NCT07758556
- Acronym / sponsor ID
- FUCDCLINIC-2403
- Conditions
- Speed of Alignment, Pain, External Root Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 11 Aug 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.
In this Clinical trial we aim to compare alignment speed, patient discomfort and root resorption between two different sequences of NiTi archwires
Detailed description
This study will establish and evaluate a set of alignment wires that is efficient in terms of reduced number of patient's visits, yet periodontally safe and acceptable in terms of patient discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment two archwires | Experimental | Device: ArchwirePatients undergoing archwire sequence as follows 0.014 inch NiTi 0.019x0.025 inch NiTi |
| Treatment with five archwires | Experimental | Device: ArchwirePatients undergoing archwire sequence as follows 0.014 inch NiTi 0.018 inch NiTi 0.020 inch NiTi 0.016x0.022 inch NiTi 0.019x0.025 inch NiTi |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age range 12-35 years.
- Both male and female patients.
- Medically-fit patients with no medical condition associated with root resorption risk.
- No previous history of orthodontic treatment.
- Patients requiring complete upper and lower orthodontic treatment with fixed appliance.
Key exclusion criteria (10 listed)
- Cleft lip \& palate patients
- Syndromic patients
- Patients with bone pathologies
- Habits such as smoking
- Patients with parafunctional habits or history of pre-existing root resorption
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 |
|---|---|---|
| ArchwireNiTi Archwires will be used for tooth alignment | Device | Treatment two archwires, Treatment with five archwires |
Primary outcome
Speed of alignment
Time frame: 6 months
Speed of alignment will be calculated in terms of number of visits and measured by Littles irregularity Index in millimeters
1 secondary outcome
Patient discomfort
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 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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.
Shoaib Rahim, FCPS study chair
FUCD & H
Rozina Nazir, FCPS study chair
FUCD & H
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Archwire in people with Speed of Alignment and Pain, run by Foundation University Islamabad at 3 sites 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 7 inclusion and 10 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Speed of alignment (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 13 Aug 2026.