Evaluation of Clinical and Patient-Reported Outcomes of Laceback

Not Applicable

Not yet recruiting

• Conditions: Malocclusion

• Registration Number: NCT07039071
• Lead Sponsor: International Islamic University Malaysia

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. 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-29
• Study Start: 2026-01-01
• Primary Completion: 2027-06
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plaque score	T0 (baseline) - before placing laceback. T1 - 3 weeks after laceback placement.	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of archwire complications	T1 - 3 weeks after laceback placement. And whenever patient comes for emergency appointment between T0 and T1.	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.
Frequency of laceback complications	T1 - 3 weeks after lacebac placement And whenever patient comes for emergency appointment between T0 and T1.	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.
Pain during orthodontic treatment	During appointment, T0 (baseline) - before laceback placement. Inside pain diary, between T0 to T1 at specific time points - 4 hours, 24 hours, 3 days, 1 week, 2 weeks, 3 weeks after laceback placement.	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.

Trial Locations

Locations (1)

Department of Orthodontics, Kulliyah of Dentistry, International Islamic University Malaysia; 🇲🇾 Kuantan, Pahang, Malaysia