An interventional study of Laceback in Malocclusion, sponsored by International Islamic University Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by International Islamic University Malaysia · Not applicable, Interventional, and Supportive care
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:
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.
Aim:
To evaluate the clinical and patient-reported outcomes of laceback usage during alignment phase of orthodontic fixed appliance treatment.
Specific Objectives:
Research questions:
Study design:
Split-mouth randomised controlled trial. 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.
Population (P) - Orthodontic patients from International Islamic University Malaysia (IIUM) aged 15 and above.
Intervention (I) - Laceback (LB) Control (C) - No laceback (no LB) Outcome (O) - Primary outcome: Plaque score (using Orthodontic Plaque Index)
Secondary outcomes:
Frequency of archwire complications Frequency of laceback complications Pain (using Visual Analogue Scale)
Study procedures:
One week after braces are put up, participants will be called back so that the researchers can put up laceback on one side of their oral cavity, and record baseline records of their oral hygiene using the Orthodontic Plaque Index (OPI). Participants are required to carry out the usual oral hygiene practices after braces and laceback are being put up. During the next 8 week 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 for 4 weeks at specific time points, where pain will be recorded using a Visual Analogue Scale. After 4 weeks, participants will be recalled so that the researchers collect the pain diary, and record the plaque score, and any archwire/laceback complications. This is repeated for another 4 weeks whereby pain diary is filled up for 4 weeks at specific time points, and on the 8th week, subjects will be reclled so that the researchers collect the pain diary, and record the plaque score, and any archwire/laceback complications.
Sampling method:
Convenience sampling of orthodontic patients from the Specialist and Postgraduate Orthodontic Clinic of the Kulliyyah of Dentistry, IIUM.
Sample size calculation:
Sample size is calculated based on each specific objective. Sample size calculated for specific objective 1 was the highest and was therefore chosen.
Specific objective 1 is to assess the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment. A previous split-mouth study was conducted on orthodontic patients to record their plaque score using OPI. The standard deviation (SD) of OPI was calculated to be 1.88. A difference of 1 point in OPI was deemed clinically meaningful to be detected. The sample size is calculated using G*Power (Version 3.1.9.6). A total of 34 subjects are required for 68 sites (34 LB and 34 no LB), which would give a power of 85% with significance level of 0.05 to detect 1 unit difference in OPI score. Final sample size after considering 10% drop out rate is 38 patients (38 per group).
Randomisation:
Two-stage randomisation strategy will be employed - simple randomisation, followed by minimisation (covariate adaptive randomisation). For the first 10 subjects, simple randomisation is applied. For the subsequent 28 subjects, allocation will be determined using minimisation method. This is to balance the prespecified covariates between laceback and no laceback groups - type of premolar extracted and side of allocating laceback.
Allocation concealment is achieved by sequentially numbered, opaque, sealed envelopes containing allocation card written "left" or "right" side for laceback. As new subjects are recruited, an independent dental nurse opens the next envelope in the sequence to reveal the allocation. The prinicipal investigator is responsible for recruiting and implementing the intervention.
Blinding:
Due to the nature of the study, the participants and operator are not blinded. Some of the data collection can be blinded, i.e. recording of plaque score. During recall visits, laceback and archwires will be removed, then plaque disclosing agent will be applied. Then, plaque score will be recorded by a clinician not involved in treating the patient. All data collected will be coded and anonymised to ensure that the data analyst is blinded. The code will be held by the co-investigator and will only be revealed to the principal investigator after data analysis is completed.
Proposed statistical analysis:
Data will be analysed using IBM SPSS Statistics for Macintosh (Version 27). Normality of data will be assessed using shape of the distribution curve and Shapiro-Wilk test. Reliability assessments will be measured using Intraclass Correlation Coefficient with threshold set at 0.8 to indicate good inter- and intra-rater reliability. An intention-to-treat analysis will be employed. Missing pain scores will be imputed by last observation carried forward method.
Baseline demographic characteristics will be analysed using descriptive statistics.
For specific objective 1, to compare differences in mean plaque score between LB and no LB group over time (T0, T1, and T2), a two-way repeated measures ANOVA test will be applied if data is normally distributed. When a significant main effect or interaction is detected, post-hoc pairwise comparisons will be performed using simple effects analysis with Bonferroni correction. If normality assumption is violated, Friedman test will be applied instead.
For specific objective 2, the mean frequency of archwire complications will be recorded by summing up the number of complications that happen throughout the study period from T0 to T2. To compare differences in mean frequency of archwire complications between LB and no LB group, a paired t-test will be used if data is normally distributed. If normality assumption is violated, Wilcoxon signed-rank test will be applied instead.
For specific objective 3, mean frequency of laceback complications per subject will be reported. The number and percentage of subjects with at least two laceback complications will also be reported.
For specific objective 4, to compare differences in mean pain score between LB and no LB group over time (T0, T0 - T1, and T1 - T2), a two-way repeated measures ANOVA test will be applied if data is normally distributed. When a significant main effect or interaction is detected, post-hoc pairwise comparisons will be performed using simple effects analysis with Bonferroni correction. If normality assumption is violated, Friedman test will be applied instead.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 38 is close to the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →International Islamic University Malaysia is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Patient factors
Orthodontic factors
Exclusion Criteria:
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
On the other side of the oral cavity, no laceback will be placed.
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).
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.
Time frame: T0 (baseline) - before placing laceback. T1 - 4 weeks after T0 T2 - 4 weeks after T1
Frequency of archwire complications
For the purpose of this study, archwire complications will include the following: * Archwire fractured at any part distal to the canine bracket - counted as one incident. * Archwire dislodged from one or more canine bracket, premolar bracket, or first molar tube - counted as one incident. * Archwire permanently deformed at any part distal to the canine bracket - counted as one incident. * Any combination of the above three situations - counted as one incident. * Whole archwire lost - counted as one incident each on both LB and no LB sides. Upper and lower archwires will be visually examined when the patient is first seen during the appointment. The number of complications of upper and lower archwires are summed up for each side. Total number of archwire complications throughout study period will be recorded for LB side and no LB side.
Time frame: 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
For the purpose of this study, laceback complications will include the following: * Laceback ligature fractured at any part - counted as one incident. * Laceback ligature dislodged from one or more brackets of canine, premolar, and first molar hook - counted as one incident. * A combination of the above two situations - counted as one incident. * Whole laceback lost - counted as one incident. Upper and lower lacebacks will be visually examined when the patient is first seen during the appointment. The number of complications of upper and lower lacebacks are summed up. Total number of laceback complications throughout study period will be recorded. During emergency appointments, dislodged lacebacks will be retied using the same protocol described previously, whereas broken or missing laceback will be replaced using new but same type of preformed 0.010" stainless steel wire ligature (Ormco Corporation, United States of America) in the same manner.
Time frame: 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
Pain on LB and no LB side will be recorded using Visual Analogue Scale (VAS) in a pain diary. Subjects will be reminded via phone to complete the diary at home, and it will be collected back during T1. They will be asked to rate the maximum pain on each side during 4 hr, 24 hr, 3 days, 1 week, 2 weeks, 3 weeks after laceback placement. Subjects will place a mark along a 100 mm horizontal line at the most relevant position, whereby the left extreme indicates "no pain and discomfort" and the right extreme indicates "worst imaginable pain and discomfort". VAS will be measured to the nearest 1 mm using a metal ruler from the low end of the scale to the patient's mark (score 0-100). Each pain score reading will be accompanied by an open-ended question asking what is the cause of pain. Analgesics should not be taken prophylactically - score should reflect maximum pain before analgesics. From the diary, the highest pain score throughout T0-T1 is recorded for LB and no LB side.
Time frame: 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.
Plan to share: No — Patient confidentiality. And will require permission from Director General of Health Malaysia
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International Islamic University Malaysia