Evaluation of Clinical and Patient-Reported Outcomes of Laceback

ConditionMalocclusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorInternational Islamic University Malaysia

About this trial

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.

Eligibility criteria

Qualifiers

Age 15 and above

Medically fit and well

Good oral hygiene - no dental caries, Basic Periodontal Examination (BPE) score 0

Full upper and lower arch fixed orthodontic treatment (bonded till first permanent molars)

Disqualifiers

Craniofacial deformities

Mental or physical disability leading to impaired manual dexterity, difficulty in comprehending and following oral hygiene instructions

Underlying chronic medical illness, oral diseases

Trial design

Treatments tested in this trial

  • Laceback

Treatment groups

38 Participants
are divided into 2 treatment groups