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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05676840
Other study ID # 1431019DSAOM
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date June 2024

Study information

Verified date April 2023
Source Ziauddin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date June 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - lower anterior crowding good oral hygeine all permanent lower incisors no previous orthodontic treatment Exclusion Criteria: - extracted or missing lower incisors poor oral hygeine relevant medical history previous orthodontic treatment

Study Design


Related Conditions & MeSH terms

  • Crowding of Anterior Mandibular Teeth

Intervention

Procedure:
orthodontic treatment with fixed appliances
comprehensive orthodontic treatment with fixed orthodontic appliances for the correction of misaligned teeth.

Locations

Country Name City State
Pakistan Ziauddin University Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparing the alignment efficiency of three types of NiTi archwires. alignment of lower anterior crowding 4 months
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