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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:
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.
Full description
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 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.
Enrollment
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Inclusion criteria
Patient factors
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Exclusion criteria
Primary purpose
Allocation
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Masking
38 participants in 2 patient groups
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Central trial contact
Assistant Professor Dr. Siti Hajjar Binti Nasir; Dr. Tan Loon Han
Data sourced from clinicaltrials.gov
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