NCT07758556

Brief Summary

In this Clinical trial we aim to compare alignment speed, patient discomfort and root resorption between two different sequences of NiTi archwires

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Speed of alignment

    Speed of alignment will be calculated in terms of number of visits

    6 months

Secondary Outcomes (1)

  • Patient discomfort

    6 months

Other Outcomes (1)

  • Root resorption

    6 months

Study Arms (2)

Group A

EXPERIMENTAL

Patients undergoing archwire sequence as follows 0.014 inch NiTi 0.019x0.025 inch NiTi

Device: Archwire

Group B

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

Device: Archwire

Interventions

ArchwireDEVICE

NiTi Archwires will be used for tooth alignment

Group AGroup B

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foundation University Islamabad

Islamabad, Punjab Province, 04403, Pakistan

Location

FUI

Islamabad, Punjab Province, 43000, Pakistan

Location

FUI

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shoaib Rahim, FCPS

    FUCD & H

    STUDY CHAIR
  • Rozina Nazir, FCPS

    FUCD & H

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will have no idea which group of archwires they are included in
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

December 20, 2024

Primary Completion

July 2, 2025

Study Completion

September 2, 2025

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations