Evaluation of Clinical and Patient-Reported Outcomes of Laceback
NCT ID: NCT07039071
Last Updated: 2025-06-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
38 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-31
Study Completion Date
2027-09-30
Brief Summary
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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.
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.
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Detailed Description
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Aim:
To evaluate the clinical and patient-reported outcomes of laceback usage during alignment phase of orthodontic fixed appliance treatment.
Specific Objectives:
1. To assess the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment.
2. To investigate the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment.
3. To determine the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment.
4. To study the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment.
Research questions:
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?
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 three 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 3 weeks at specific time points, where pain will be recorded using a Visual Analogue Scale. After 3 weeks, participants will be recalled 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:
Simple randomisation method will be employed. The sequence will be generated using Microsoft Excel by a co-investigator not involved in the trial. Equal number of left and right sides are allocated for laceback intervention. Sequentially numbered, opaque, sealed envelopes containing allocation card written "left" or "right" side for laceback will be prepared. 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. Plaque score, frequency of archwire complications, and pain between LB and no LB side will be compared using paired t-test or Wilcoxon signed-rank test depending on the distribution of data.
To evaluate the clinical and patient-reported outcomes of laceback usage during alignment phase of orthodontic fixed appliance treatment.
Specific Objectives:
1. To assess the effect of laceback on patient's oral hygiene during alignment phase of orthodontic fixed appliance treatment.
2. To investigate the effect of laceback on the frequency of archwire complications during alignment phase of orthodontic fixed appliance treatment.
3. To determine the frequency of laceback complications during alignment phase of orthodontic fixed appliance treatment.
4. To study the effect of laceback on pain during alignment phase of orthodontic fixed appliance treatment.
Research questions:
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?
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 three 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 3 weeks at specific time points, where pain will be recorded using a Visual Analogue Scale. After 3 weeks, participants will be recalled 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:
Simple randomisation method will be employed. The sequence will be generated using Microsoft Excel by a co-investigator not involved in the trial. Equal number of left and right sides are allocated for laceback intervention. Sequentially numbered, opaque, sealed envelopes containing allocation card written "left" or "right" side for laceback will be prepared. 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. Plaque score, frequency of archwire complications, and pain between LB and no LB side will be compared using paired t-test or Wilcoxon signed-rank test depending on the distribution of data.
Conditions
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Malocclusion
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
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.
Study Groups
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Laceback
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.
Group Type
EXPERIMENTAL
Laceback
Intervention Type
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).
No laceback
On the other side of the oral cavity, no laceback will be placed.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Laceback
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).
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* Mental or physical disability leading to impaired manual dexterity, difficulty in comprehending and following oral hygiene instructions
* Underlying chronic medical illness, oral diseases
Minimum Eligible Age
15 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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International Islamic University Malaysia
OTHER
Sponsor Role
lead
Responsible Party
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Tan Loon Han
Postgraduate Orthodontic Resident
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Assistant Professor Dr. Siti Hajjar Binti Nasir
Role: STUDY_CHAIR
International Islamic University Malaysia
Locations
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Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia
Kuantan, Pahang, Malaysia
Site Status
Countries
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Malaysia
Central Contacts
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Facility Contacts
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References
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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.
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V 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.
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Usmani 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.
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Sueri MY, Turk T. Effectiveness of laceback ligatures on maxillary canine retraction. Angle Orthod. 2006 Nov;76(6):1010-4. doi: 10.2319/100605-351.
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Raja 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.
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Kozak 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.
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Popat 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.
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Peterson 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.
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Pandis 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.
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Pandis 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.
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Mokhtari 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.
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McLaughlin RP, Bennett JC. The transition from standard edgewise to preadjusted appliance systems. J Clin Orthod. 1989 Mar;23(3):142-53. No abstract available.
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Marsh PD. Dental plaque as a microbial biofilm. Caries Res. 2004 May-Jun;38(3):204-11. doi: 10.1159/000077756.
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Marincak 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.
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BACKGROUND
Koo 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.
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Jiang HM, Yu C, Kan Q, Xu B, Ma C, Kang G. Effect of hydrogen on super-elastic behavior of NiTi shape memory alloy wires: Experimental observation and diffusional-mechanically coupled constitutive model. J Mech Behav Biomed Mater. 2022 Aug;132:105276. doi: 10.1016/j.jmbbm.2022.105276. Epub 2022 May 20.
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Jakubovics NS, Goodman SD, Mashburn-Warren L, Stafford GP, Cieplik F. The dental plaque biofilm matrix. Periodontol 2000. 2021 Jun;86(1):32-56. doi: 10.1111/prd.12361. Epub 2021 Mar 10.
Reference Type
BACKGROUND
Irvine R, Power S, McDonald F. The effectiveness of laceback ligatures: a randomized controlled clinical trial. J Orthod. 2004 Dec;31(4):303-11; discussion 300. doi: 10.1179/146531204225020606.
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BACKGROUND
Inauen DS, Papadopoulou AK, Eliades T, Papageorgiou SN. Pain profile during orthodontic levelling and alignment with fixed appliances reported in randomized trials: a systematic review with meta-analyses. Clin Oral Investig. 2023 May;27(5):1851-1868. doi: 10.1007/s00784-023-04931-5. Epub 2023 Mar 6.
Reference Type
BACKGROUND
Guzman U, Jerrold L, Abdelkarim A. An in vivo study on the incidence and location of fracture in round orthodontic archwires. J Orthod. 2013 Dec;40(4):307-12. doi: 10.1179/1465313313Y.0000000062.
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BACKGROUND
Fleming PS, Johal A, Pandis N. The effectiveness of laceback ligatures during initial orthodontic alignment: a systematic review and meta-analysis. Eur J Orthod. 2013 Aug;35(4):539-46. doi: 10.1093/ejo/cjs033. Epub 2012 Apr 26.
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BACKGROUND
Dowsing P, Murray A, Sandler J. Emergencies in orthodontics. Part 1: Management of general orthodontic problems as well as common problems with fixed appliances. Dent Update. 2015 Mar;42(2):131-4, 137-40. doi: 10.12968/denu.2015.42.2.131.
Reference Type
BACKGROUND
Beberhold K, Sachse-Kulp A, Schwestka-Polly R, Hornecker E, Ziebolz D. The Orthodontic Plaque Index: an oral hygiene index for patients with multibracket appliances. Orthodontics (Chic.). 2012;13(1):94-9.
Reference Type
BACKGROUND
Badran SA, Al-Zaben JM, Al-Taie LM, Tbeishi H, Al-Omiri MK. Comparing patient-centered outcomes and efficiency of space closure between nickel-titanium closed-coil springs and elastomeric power chains during orthodontic treatment. Angle Orthod. 2022 Jul 1;92(4):471-477. doi: 10.2319/120721-906.
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Al-Anezi SA, Harradine NW. Quantifying plaque during orthodontic treatment: Angle Orthod. 2012 Jul;82(4):748-53. doi: 10.2319/050111-312.1. Epub 2011 Nov 1.
Reference Type
BACKGROUND
Other Identifiers
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IIUM_Laceback
Identifier Type: -
Identifier Source: org_study_id
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