Evaluation of Clinical and Patient-Reported Outcomes of Laceback

ConditionMalocclusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorInternational Islamic University Malaysia

About this 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:

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 15 and above

Medically fit and well

Good oral hygiene - no dental caries, Basic Periodontal Examination (BPE) score 0

Full upper and lower arch fixed orthodontic treatment (bonded till first permanent molars)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Laceback

    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).

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: LacebackExperimental treatment 1 intervention
Group B: No lacebackNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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.

Other outcomes

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