Improvement in Class II Molar Relationship Among Orthodontic Patients Reminded Through Text Message and Phone Call as Compared to No Reminders for Wearing Class II Elastics -A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Improvement in class II molar relationship by using an overjet scale among orthodontic patients through reminders.
研究概览
简要总结
The objective of this study is to determine the difference in improvement in class II molar relationship among orthodontic patients reminded daily through text message, weekly through phone call as compared to no reminders for wearing class II elastics.
详细描述
Compliance is an important factor for better orthodontic treatment outcome. To find the best strategy for promoting better communication between patients and doctors and to increase the patient adherence to treatment especially in the field of oral health. This study will help us to find out the best and effective modality for efficient treatment outcomes and to avoid any side effects which can occur due to un-cooperation of patients in wearing appliances.
SAMPLE SIZE:
Sample size was calculated using the following formula:
By using the findings of Richter et al.16 who reported a mean improvement in compliance with high reward group as (64.6 ± 12.8), high award group (68.2 ± 7.8) and for no reminder group as (71.8 ± 6.2). We will require a minimum sample size of 51 orthodontic patients with 17 patients in group 1(reminded daily via whatsapp text message), 17 in group 2 (patients who will be asked through a weekly phone call about elastic wear and then motivated) and 17 in group 3 (patients who will not be reminded or motivated through social media) with an inflation of 10 % for loss to follow up/non-response rate, to achieve 80% power with atleast 10% change in compliance and 10% or less change in coefficient of variation at two sided 5% level of significance.
Settings: Dental clinics, Aga Khan University Hospital, Karachi (AKUH) Study Design: Randomized open label control trial Allocation: Parallel design with 1:1:1 allocation ratio Duration of Study: January - September2024 Sampling Technique: Non probability purposive sampling Allocation: Random block allocation with a block size of 2, 4 and 6
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects will be assigned to one of the three study groups using a computer generated randomization list. There will be no blinding in the study. The recruitment of the patients will be performed by the investigator who will explain the objective, the three arms of the study and the allocation to the participants. Allocation concealment will be carried out using opaque concealed envelopes which will be opened until the use of intervention is to be explained to the patient.
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 15 - 50 years with permanent dentition.
- •Patients undergoing fixed orthodontic treatment and requires class II elastics for correcting molar relationship as a part of their treatment plan.
- •All patients who will sign the informed consent form.
- •Patients having access to smartphones.
排除标准
- •Patients with uncontrolled periodontal disease or pulpitis.
- •Presence of any dental/ craniofacial anomaly or syndrome like hemifacial microsomia, Downs syndrome, Treacher Collins syndrome, etc
结局指标
主要结局
Improvement in class II molar relationship by using an overjet scale among orthodontic patients through reminders.
时间窗: 6 months
Reminders will be given daily through text message, weekly through phone call as compared to no reminders for wearing class II elastics. An overjet scale consisting of markings in mm will be used to measure the distance from mesial of the band of lower first permanent mandibular molar to cusp tip of upper canine.
次要结局
未报告次要终点
研究者
Rashna Hoshang Sukhia
Principal Investigator
Aga Khan University Hospital, Pakistan