MalocclusionNCT07039071
Evaluation of Clinical and Patient-Reported Outcomes of Laceback
A study testing Laceback in people with Malocclusion, run by International Islamic University Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Malocclusion
- What is being tested?
- Laceback
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia
Kuantan, Pahang, 25200
Assistant Professor Dr. Siti Hajjar Binti Nasir, +6095705505, drhajjar@iium.edu.my
Assistant Professor Dr. Cheong Joo Ming, +6095705484, alvinjooming@iium.edu.my
About this study
Official title: Evaluation of Clinical and Patient-Reported Outcomes of Laceback: A Split-Mouth Randomised Controlled 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:
Read more
- What is the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment?
- What is the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment?
- What is the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment?
- 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.
Read the detailed description
Aim:
To evaluate the clinical and patient-reported outcomes of laceback usage during alignment phase of orthodontic fixed appliance treatment.
Specific Objectives:
- To assess the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment.
- To investigate the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment.
- To determine the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment.
- To study the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment.
Research questions:
- What is the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment?
- What is the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment?
- What is the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment?
- What is the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment?
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.
- Conditions
- Malocclusion
- Being tested
- Laceback
- Keywords
- laceback, pain, plaque score, archwire, complication, breakage
- Medical subject headings
- Malocclusion, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacebackDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laceback |
| No laceback | No intervention | On the other side of the oral cavity, no laceback will be placed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 (baseline) - before placing laceback. T1 - 4 weeks after T0 T2 - 4 weeks after T1
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start9 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Loon Han, International Islamic University Malaysia
- Investigators
- Assistant Professor Dr. Siti Hajjar Binti Nasir, Study chair, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039071
- Sponsor's protocol ID
- IIUM_Laceback
- Status last verified
- May 2026
- First submitted
- 18 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient confidentiality. And will require permission from Director General of Health Malaysia
Publications
Zinelis S, Eliades T, Pandis N, Eliades G, Bourauel C. Why do nickel-titanium archwires fracture intraorally? Fractographic analysis and failure mechanism of in-vivo fractured wires. Am J Orthod Dentofacial Orthop. 2007 Jul;132(1):84-9. doi: 10.1016/j.ajodo.2005.11.039.
PubMed 17628255V S B, Kaul A, Tiwari A, Aliya S, Yadav A, Bera T, Kaur Makkad P. Assessment of Various Archwire Materials and Their Impact on Orthodontic Treatment Outcomes. Cureus. 2024 Sep 18;16(9):e69667. doi: 10.7759/cureus.69667. eCollection 2024 Sep.
PubMed 39429425Usmani T, O'Brien KD, Worthington HV, Derwent S, Fox D, Harrison S, Sandler PJ, Mandall NA. A randomized clinical trial to compare the effectiveness of canine lacebacks with reference to canine tip. J Orthod. 2002 Dec;29(4):281-6; discussion 277. doi: 10.1093/ortho/29.4.281.
PubMed 12444268Sueri MY, Turk T. Effectiveness of laceback ligatures on maxillary canine retraction. Angle Orthod. 2006 Nov;76(6):1010-4. doi: 10.2319/100605-351.
PubMed 17090165Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
PubMed 32694387Kozak U, Lasota A, Chalas R. Changes in Distribution of Dental Biofilm after Insertion of Fixed Orthodontic Appliances. J Clin Med. 2021 Nov 29;10(23):5638. doi: 10.3390/jcm10235638.
PubMed 34884339Popat H, Thomas K, Farnell DJ. Management of orthodontic emergencies in primary care - self-reported confidence of general dental practitioners. Br Dent J. 2016 Jul 8;221(1):21-4. doi: 10.1038/sj.bdj.2016.495.
PubMed 27388086Peterson BW, Tjakkes GH, Renkema AM, Manton DJ, Ren Y. The oral microbiota and periodontal health in orthodontic patients. Periodontol 2000. 2024 Jul 19. doi: 10.1111/prd.12594. Online ahead of print.
PubMed 39031969Pandis N, Walsh T, Polychronopoulou A, Katsaros C, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013 Dec;35(6):783-9. doi: 10.1093/ejo/cjs108. Epub 2013 Feb 1.
PubMed 23376899Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017 Jun 30;357:j2835. doi: 10.1136/bmj.j2835.
PubMed 28667088Mokhtari S, Sanati I, Babaki FA, Alamdari S, Tavana N. Investigating the effect of handedness on the dental caries pattern, gingival index, and plaque index in 6-10 years old children. Niger J Clin Pract. 2020 Apr;23(4):545-549. doi: 10.4103/njcp.njcp_600_19.
PubMed 32246663McLaughlin RP, Bennett JC. The transition from standard edgewise to preadjusted appliance systems. J Clin Orthod. 1989 Mar;23(3):142-53. No abstract available.
PubMed 2606968Marsh PD. Dental plaque as a microbial biofilm. Caries Res. 2004 May-Jun;38(3):204-11. doi: 10.1159/000077756.
PubMed 15153690Marincak Vrankova Z, Rousi M, Cvanova M, Gachova D, Ruzicka F, Hola V, Lochman J, Izakovicova Holla L, Brysova A, Borilova Linhartova P. Effect of fixed orthodontic appliances on gingival status and oral microbiota: a pilot study. BMC Oral Health. 2022 Oct 27;22(1):455. doi: 10.1186/s12903-022-02511-9.
PubMed 36303145Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
PubMed 27330520
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Patient-Reported Outcomes of Laceback: A Split-Mouth Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07039071
- Acronym / sponsor ID
- IIUM_Laceback
- Conditions
- Malocclusion
- Keywords
- laceback, pain, plaque score, archwire, complication, breakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment?
- What is the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment?
- What is the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment?
- 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.
Detailed description
Aim:
To evaluate the clinical and patient-reported outcomes of laceback usage during alignment phase of orthodontic fixed appliance treatment.
Specific Objectives:
- To assess the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment.
- To investigate the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment.
- To determine the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment.
- To study the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment.
Research questions:
- What is the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment?
- What is the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment?
- What is the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment?
- What is the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment?
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Laceback | Experimental | Device: LacebackFor 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. |
| No laceback | No intervention | –On the other side of the oral cavity, no laceback will be placed. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient factors
- Age 15 and above
- Medically fit and well
- Good oral hygiene - no dental caries, Basic Periodontal Examination (BPE) score 0
- Orthodontic factors
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacebackLacebacks 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). | Device | Laceback |
Primary outcome
Plaque score
Time frame: T0 (baseline) - before placing laceback. T1 - 4 weeks after T0 T2 - 4 weeks after T1
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.
3 secondary outcomes
Frequency of archwire complications
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 17628255Zinelis S, Eliades T, Pandis N, Eliades G, Bourauel C. Why do nickel-titanium archwires fracture intraorally? Fractographic analysis and failure mechanism of in-vivo fractured wires. Am J Orthod Dentofacial Orthop. 2007 Jul;132(1):84-9. doi: 10.1016/j.ajodo.2005.11.039.
- Background: PubMed 39429425V S B, Kaul A, Tiwari A, Aliya S, Yadav A, Bera T, Kaur Makkad P. Assessment of Various Archwire Materials and Their Impact on Orthodontic Treatment Outcomes. Cureus. 2024 Sep 18;16(9):e69667. doi: 10.7759/cureus.69667. eCollection 2024 Sep.
- Background: PubMed 12444268Usmani T, O'Brien KD, Worthington HV, Derwent S, Fox D, Harrison S, Sandler PJ, Mandall NA. A randomized clinical trial to compare the effectiveness of canine lacebacks with reference to canine tip. J Orthod. 2002 Dec;29(4):281-6; discussion 277. doi: 10.1093/ortho/29.4.281.
- Background: PubMed 17090165Sueri MY, Turk T. Effectiveness of laceback ligatures on maxillary canine retraction. Angle Orthod. 2006 Nov;76(6):1010-4. doi: 10.2319/100605-351.
- Background: PubMed 32694387Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
- Background: PubMed 34884339Kozak U, Lasota A, Chalas R. Changes in Distribution of Dental Biofilm after Insertion of Fixed Orthodontic Appliances. J Clin Med. 2021 Nov 29;10(23):5638. doi: 10.3390/jcm10235638.
- Background: PubMed 27388086Popat H, Thomas K, Farnell DJ. Management of orthodontic emergencies in primary care - self-reported confidence of general dental practitioners. Br Dent J. 2016 Jul 8;221(1):21-4. doi: 10.1038/sj.bdj.2016.495.
- Background: PubMed 39031969Peterson BW, Tjakkes GH, Renkema AM, Manton DJ, Ren Y. The oral microbiota and periodontal health in orthodontic patients. Periodontol 2000. 2024 Jul 19. doi: 10.1111/prd.12594. Online ahead of print.
- Background: PubMed 23376899Pandis N, Walsh T, Polychronopoulou A, Katsaros C, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013 Dec;35(6):783-9. doi: 10.1093/ejo/cjs108. Epub 2013 Feb 1.
- Background: PubMed 28667088Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017 Jun 30;357:j2835. doi: 10.1136/bmj.j2835.
- Background: PubMed 32246663Mokhtari S, Sanati I, Babaki FA, Alamdari S, Tavana N. Investigating the effect of handedness on the dental caries pattern, gingival index, and plaque index in 6-10 years old children. Niger J Clin Pract. 2020 Apr;23(4):545-549. doi: 10.4103/njcp.njcp_600_19.
- Background: PubMed 2606968McLaughlin RP, Bennett JC. The transition from standard edgewise to preadjusted appliance systems. J Clin Orthod. 1989 Mar;23(3):142-53. No abstract available.
- Individual participant dataSharing planned: No. Patient confidentiality. And will require permission from Director General of Health Malaysia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assistant Professor Dr. Siti Hajjar Binti Nasir study chair
International Islamic University Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laceback in people with Malocclusion, run by International Islamic University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Tan Loon Han (+60123790908, tanloonhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque score (time frame: T0 (baseline) - before placing laceback. T1 - 4 weeks after T0 T2 - 4 weeks after T1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07039071, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.