Evaluation of Clinical and Patient-Reported Outcomes of Laceback

Launched by INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how using a special orthodontic method called lacebacks affects patients during braces treatment. Lacebacks are small elastic bands used along with braces to help align teeth. The researchers want to find out how lacebacks influence oral hygiene (how clean your teeth stay), how often problems happen with the braces wires or lacebacks themselves, and how much pain patients feel while wearing them. To do this, each participant will have lacebacks applied on one side of their mouth, while the other side will have regular braces without lacebacks. This way, the researchers can directly compare the two sides in the same person.

People who might take part are those 15 years or older who are generally healthy, have good oral hygiene with no cavities or gum disease, and are starting full braces treatment on both upper and lower teeth after having certain teeth removed. Participants will keep up their regular teeth cleaning routines and report any issues like broken parts or loose bands so they can get checked quickly. They will also keep a diary to record any pain they experience. This study aims to help both patients and orthodontists understand if lacebacks make braces treatment more comfortable and easier to manage.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient factors
• • Age 15 and above
• • Medically fit and well
• • Good oral hygiene - no dental caries, Basic Periodontal Examination (BPE) score 0
• • Orthodontic factors
• • Full upper and lower arch fixed orthodontic treatment (bonded till first permanent molars)
• • Pre-adjusted edgewise appliance with 0.022" slot, MBT prescription, Master Series® brackets (American Orthodontics, USA)
• • Extraction of bilateral upper and lower permanent first/second premolars
• • No previous orthodontic treatment
• Exclusion Criteria:
• • 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