Clinical Effectiveness of the Calcium Chloride (CaCl2) Surface- Treated Orthodontic Mini Implant (OMI) in a Split-Mouth Randomised Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Maximum insertion torque and removal torque
研究概览
简要总结
The goal of this split mouth, randomised control study was to compare the clinical effectiveness of surface treated Calcium Chloride orthodontic mini implant in orthodontic patients. The main question[s] it aimed to answer were:
Does the clinical effectiveness based on overall stability in maximum insertion torque and maximum removal torque measurement vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?, Does the surface roughness of OMI surface post removal vary between untreated surface OMI, treated surface OMI with acid etching only and treated-surface MI with acid etching and calcium chloride immersion? Does the success rate vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?Does the oral health quality of life and pain vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion? Participants who is eligible for the study , orthodontic patient requiring moderate to high anchorage will be allocated to 2 groups (Group 1 : calcium chloride and control, Group 2 : acid etch, and control) to be used during the orthodontic treatment. The intervention is calcium chloride; the Calcium Chloride, positive control is the acid-etched and control is the machined group OMI. Comparison of the maximum insertion and removal torque, oral health quality of life, success rate and the surface roughness between the different groups of OMI.
详细描述
1.1 Study Design A triple-blinded, three-arm parallel-group randomized controlled trial was conducted at a single center. The trial assesses the effectiveness of an intervention through a split-mouth clinical study design.
1.2 Study Duration This study was carried out from January 2023 until March 2024.
1.3 Ethical Approval Ethical approval (REC/09/2021(FB/56) dated 17 December 2021 was obtained from the Universiti Teknologi MARA Research Ethics Committee (UiTM REC) to carry out the study at Tourmaline Postgraduate Dental Clinic, Faculty of Dentistry, UiTM. This study was conducted by following the ICH Clinical Practice Guidelines, Malaysia Good Clinical Practice Guidelines and the Declaration of Helsinki. (Appendix 1). Informed consent procedures were detailed, outlining participant recruitment methods and the process by which participants were informed about the study's purpose, risks, benefits, confidentiality measures, and their right to withdraw.
1.4 Reference Population Orthodontic patients requiring fixed appliance treatment involving extractions of at least one premolar in each quadrant with moderate to high anchorage demand.
1.5 Source Population Registered patient attending clinics in Faculty of Dentistry UiTM who require fixed appliance with moderate to high anchorage demand.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
sealed envelop
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range between 18 and 40 years
- •Good oral hygiene1
- •Patients prescribed with fixed appliance who require extraction of at least one premolar at each quadrant.
- •Moderate anchorage demand criteria
- •Class II/1 incisor relationship
排除标准
- •History of previous orthodontic treatment
- •Patient who requires combination of orthodontic and orthognathic surgery
- •Medically compromised2 or patients who is taking any medication that interferes with bone metabolism.
- •Presence of craniofacial syndromes or clefts
- •Active periodontal disease
- •Poor oral hygiene prior to orthodontic treatment
结局指标
主要结局
Maximum insertion torque and removal torque
时间窗: During procedure
Measurement of torque during insertion and removal of the mini implant. The higher the Ncm value, the higher is the stability of the mini implant. The values are directly proportionate to the stability.
次要结局
- Oral Health Quality of Life(During procedure)
- The surface roughness characteristics of the mini implant(at the end of the study at 12 months)
- Success rate of mini implant(From enrolment to 6 months)
研究者
Suzanne Husun Reginald Iggan
Dr
Universiti Teknologi Mara