- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07758556
Comparison of Alignment Speed, Patient Discomfort and Root Resorption Between Two Different Sequences of Archwires
August 11, 2026 updated by: Shoaib Rahim, Foundation University Islamabad
In this Clinical trial we aim to compare alignment speed, patient discomfort and root resorption between two different sequences of NiTi archwires
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Islamabad, Punjab Province, Pakistan, 04403
- Foundation University Islamabad
-
Islamabad, Punjab Province, Pakistan, 43000
- FUI
-
Islamabad, Punjab Province, Pakistan, 46000
- FUI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment two archwires
Patients undergoing archwire sequence as follows 0.014 inch NiTi 0.019x0.025
inch NiTi
|
NiTi Archwires will be used for tooth alignment
|
|
Experimental: Treatment with five archwires
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
|
NiTi Archwires will be used for tooth alignment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient discomfort
Time Frame: 6 months
|
Will be measured as scoring on pain proforma on Visual analogue scale
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Root resorption
Time Frame: 6 months
|
Will be measured on periapical radiographs before and after alignment
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shoaib Rahim, FCPS, FUCD & H
- Study Chair: Rozina Nazir, FCPS, FUCD & H
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2024
Primary Completion (Actual)
July 2, 2025
Study Completion (Actual)
September 2, 2025
Study Registration Dates
First Submitted
August 6, 2026
First Submitted That Met QC Criteria
August 6, 2026
First Posted (Actual)
August 11, 2026
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUCDCLINIC-2403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.