Comparison of the pain perception and transverse changes following expansion with quad helix appliance fabricated from stainless steel and titanium molybdenum alloy among patients with unilateral cleft lip and palate: a randomized clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To assess and compare pain and discomfort of following expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate using Visual Analogue Scale (VAS) and Modified McGill Pain Questionnaires.
研究概览
简要总结
To compare the pain perception and transverse dentoskeletal changes in the maxilla following expansion with Quad Helix appliance fabricated from Stainless Steel (SS) and Titanium Molybdenum Alloy (TMA) among the patients with unilateral cleft lip and palate. The objectives are to assess and compare pain and discomfort of following expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate at 4 hours, at 6 hours, 24 hours, at 2 days, at 7 days using Visual Analogue Scale (VAS) and Modified McGill Pain Questionnaires and also to assess and compare the transverse skeletal changes in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on CBCT and to assess and compare the change in intercanine and intermolar width in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on plaster study models. Total sample size is 28 with 14 in each group. Only those patients with UCLP in need of maxillary expansion will be recruited and fully informed and proper consent will be taken. The Quadhelix appliance is a non invasive appliance used for dental expansion which will be placed without any surgical intervention on a day care basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with unilateral cleft lip and palate (Group 3) with unilateral or bilateral crossbite in need of bilateral expansion for crossbite correction Age group: 8-13 years Mixed dentition and permanent dentition period Patients who consent to participate in the study.
排除标准
- •Patients who had undergone previous orthodontic treatment for expansion Craniofacial anomalies Absence of maxillary permanent first molars.
结局指标
主要结局
To assess and compare pain and discomfort of following expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate using Visual Analogue Scale (VAS) and Modified McGill Pain Questionnaires.
时间窗: At 4 hours, at 6 hours, at 24 hours, at 2 days and at 7 days
次要结局
- To assess and compare the transverse skeletal changes in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on CBCT.(pre treatment and at 3 months)
- To assess and compare the change in intercanine and intermolar width in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on plaster study models(at pretreatment and at 3 months)
研究者
Dr Ashwin T
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH