Evaluation of Clinical and Patient-Reported Outcomes of Laceback

NCT07039071 | Not Yet Recruiting

• 1 other identifier: IIUM_Laceback
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Malocclusion

Keywords

laceback; pain; plaque score; archwire; complication; breakage

Outcome Measures

Primary Outcomes (1)

• Plaque score

  Plaque score will be recorded using Orthodontic Plaque Index (OPI). After removing laceback and archwires, the OPI is scored by blinded clinician after applying plaque disclosing agent on canine, premolar, first molar. Visually examine presence/absence of plaque at tooth surface adjacent to bracket base (mesial, distal, occlusal, gingival), and the condition of the gingival margin. The status is scored according to the criteria below: Score 0 - Brackets are plaque-free Score 1 - Plaque on 1 tooth surface at bracket base Score 2 - Plaque on 2 tooth surfaces at bracket base Score 3 - Plaque on 3 tooth surfaces at bracket base Score 4 - Plaque on 4 tooth surfaces at bracket base and/or gingival inflammation Mean OPI for LB and no LB side is calculated by adding up plaque score of all the teeth recorded on each side, and dividing it by the number of teeth scored. Inter and intrarater reliability testing will be done.

  T0 (baseline) - before placing laceback. T1 - 4 weeks after T0 T2 - 4 weeks after T1

Secondary Outcomes (3)

• Frequency of archwire complications

  T1 - 4 weeks after T0 T2 - 4 weeks after T1 And whenever patient comes for emergency appointment between T0 and T1, and T1 to T2

• Frequency of laceback complications

  T1 - 4 weeks after T0 T2 - 4 weeks after T1 And whenever patient comes for emergency appointment between T0 and T1, and T1 an T2

• Pain during orthodontic treatment

  During appointment, T0 (baseline) - before laceback placement. Inside pain diary, between T0 to T1 and T1 to T2 at specific time points - 4 hours, 24 hours, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after laceback placement.

Study Arms (2)

Laceback

EXPERIMENTAL

For this study, on the side of the oral cavity that is randomly allocated to receive laceback, lacebacks will be put on both upper and lower arches.

Device: Laceback

No laceback

NO INTERVENTION

On the other side of the oral cavity, no laceback will be placed.

Interventions

Laceback DEVICE

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).

Laceback

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Islamic University Malaysia: lead

Study Sites (1)

Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia

Kuantan, Pahang, 25200, Malaysia

Location

Related Publications (25)

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MeSH Terms

Conditions

Malocclusion; Pain

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assistant Professor Dr. Siti Hajjar Binti Nasir

  International Islamic University Malaysia

  STUDY CHAIR

Central Study Contacts

Dr. Tan Loon Han

CONTACT

+60123790908; tanloonhan@gmail.com

Assistant Professor Dr. Siti Hajjar Binti Nasir

CONTACT

+6095705505; drhajjar@iium.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Recording of plaque score will be blinded. Laceback and archwires will be removed, then plaque disclosing agent applied. Then plaque score will be recorded by a clinician not involved in the treatment of the patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Orthodontic Resident

Model Details: Split-mouth RCT - a within person trial. One side of the oral cavity will receive laceback, whereas the other side will act as control (no laceback).

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)