Evaluation of Clinical and Patient-Reported Outcomes of Laceback: A Split-Mouth Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Plaque score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
No laceback
On the other side of the oral cavity, no laceback will be placed.
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.
干预措施: Laceback (Device)
结局指标
主要结局
Plaque score
时间窗: 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.
次要结局
- Frequency of archwire complications(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(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(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.)
研究者
Tan Loon Han
Postgraduate Orthodontic Resident
International Islamic University Malaysia