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Alignment Efficiency and Coating Durability of Aesthetic Archwires

NCT03876184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-05-11

No results posted yet for this study

Summary

This study investigates the efficiency of orthodontic aesthetic archwires which are coated with tooth-colored materials and the durability of the coatings after being used. Theoretically, the coatings provide excellent aesthetics throughout treatment and faster tooth alignment. However, from our clinical experience, these claims are the opposite. Cracks and ruptures as well as archwire fractures have been noted. Therefore, it is presumed that the aesthetic archwires may not be any different from the conventional uncoated archwires.

Conditions

  • Tooth Movement

Interventions

OTHER

Aesthetic archwires

During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.Questionnaires will be answered by participants.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.

OTHER

Control group

During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.This group will not answer the questionnaire.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Anis F Kamaruddin, MOrth · Advanced Medical & Dental Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876184 on ClinicalTrials.gov