Comparison of two different initial arch wires for tooth alignment during fixed orthodontic treatment- A clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate and compare the aligning efficiency of 0.016 in superplastic Niti and 0.016 Heat activated niti
研究概览
简要总结
The aim of the study is to clinically evaluate and compare two different initial aligning arch wires: conventional Ni-Ti and superelastic Ni-Ti in relation to the alignment efficiency, root resorption and pain intensity. The null hypothesis will be that there is no significant difference in the rate of alignment, pain intensity and root resorption during aligning phase using two different initial aligning archwires. The present study will be conducted in the Department of Orthodontics and Dentofacial orthopedics, I.T.S - Centre for Dental studies and research, Muradnagar, Uttar Pradesh, India. Twenty patients requiring fixed orthodontic treatment will be selected to participate in the study according to the following criteria:
Inclusion criteria
Patients aged 15-25 yrs of age.
Patients requiring fixed orthodontic treatment with extraction of 1st premolars.
Patients with crowding in lower anterior segment having a mandibular irregularity index 5-8.
Patients with no relevant medical history.
no recent history of intake of drugs such as non steroidal anti inflammatory drugs.
Exclusion criteria
Subjects with systemic diseases.
Patients with active periodontal disease
Patients who have undergone previous active orthodontic treatment.
Patients with spacing in the lower anterior region.
Patients with a blocked-out tooth that do not allow for placement of the bracket at the initial bonding appointment.
**Methodology:**The study will be conducted on 20 patients using two different initial aligning archwires i.e. conventional Ni-Ti (test group A) and superelastic Ni-Ti wire (test group B) for the alignment of the mandibular arches. All the patients selected for the study will receive MBT prescription with 0.022x0.028 inch slot size.
The rate of alignment will be assessed in the mandibular arch. Good quality alginate impressions will be taken at the pre-alignment phase. After the placement of bonded attachments and bands, the aligning archwire will be placed using elastomeric ligatures. The patient will be recalled every month and a good quality alginate impression will be taken. This procedure will be conducted till archwire does not show any deflection at any site anteriorly regardless of remaining buccal irregularities.
After the placement of initial aligning archwires, the patient will be asked to record the pain and discomfort after 24 hours and 1 week after the placement of the archwire on a visual analogue scale.
In this study pre treatment CBCT radiographs of the patients will be taken to determine the root length of mandibular anterior teeth. After the completion of the aligning phase of the treatment, a post-alignment CBCT will be done to assess the root resorption during the aligning phase.
The data will be tabulated and sent for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients requiring fixed orthodontic treatment with extraction of 1st premolars.
- •Patients with crowding in lower anterior segment having a mandibular irregularity index 5-
- •Patients with no relevant medical history.
- •no recent history of intake of drugs such as non-steroidal anti-inflammatory drugs.
排除标准
- •Patients with systemic diseases, active periodontal disease, spacing in lower anterior region and those who had undergone previously orthodontic treatment.
结局指标
主要结局
To evaluate and compare the aligning efficiency of 0.016 in superplastic Niti and 0.016 Heat activated niti
时间窗: every 3 weeks till end of completely aligned.
次要结局
- To evaluate and compare the pain due to 0.016 in superplastic Niti and 0.016 Heat activated niti in aligning phase(24 hrs and 1 week after placement of wire)
- To evaluate and compare the root resorption due to 0.016 in superplastic Niti and 0.016 Heat activated niti(before wire placement and post alignment)