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Evaluation of Clinical and Patient-Reported Outcomes of Laceback

NCT07039071 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-05-13

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate oral hygiene status, archwire complications, laceback complications, and pain while using lacebacks in patients undergoing orthodontic fixed appliance treatment.

The main questions it aims to answer are:

1. What is the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment?
2. What is the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment?
3. What is the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment?
4. What is the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment?

For each subject, researchers will randomly assign half of the oral cavity to receive laceback during orthodontic fixed appliance treatment, whereas the other half will not receive laceback. Researchers will then compare the effect of laceback on patient's oral hygiene, archwire complications, laceback complications, and pain.

Participants are required to carry out the usual oral hygiene practices after braces and laceback are being put up. During the observation period, they are required to notify the researcher if they suspect any breakages or loose components, so that they come to the clinic for emergency appointments. They are also required to fill up a pain diary.

Conditions

  • Malocclusion

Interventions

DEVICE

Laceback

Lacebacks are a kind of orthodontic auxilliaries used during the initial phase of orthodontic fixed appliance treatment, especially in premolar extraction cases. They are 0.010" stainless steel ligatures tied in figure-of-8 fashion beneath the main archwires, from the canine bracket till the first molar hook of one quadrant. For this study, on the side that is randomly allocated to receive laceback, laceback will be put on both upper and lower arches (from canine bracket to 1st molar hook).

Sponsors & Collaborators

  • International Islamic University Malaysia

    lead OTHER

Principal Investigators

  • Assistant Professor Dr. Siti Hajjar Binti Nasir · International Islamic University Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2027-06-30
Completion
2027-09-30

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 NCT07039071 on ClinicalTrials.gov