Comparison of two treatment protocols - SEFA III and SEA III for developing dentoskeletal Class III correction - an institutional based randomized clinical study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- primary outcome measures the skeletal and dental dimensional changes in Class III patients following SEFA III
研究概览
简要总结
Dentoskeletal class III malocclusion is characterized as increased growth of lower jaw or deficient growth of upper jaw or the combination. Most of the cases, the malocclusion is accompanied by dental compensations. The objective of this study is to compare the effectiveness of two treatment protocols- SEA III (involving only intra oral appliances) and SEFA III (involves intra oral and extra oral appliances).The research will be conducted in the Department of Orthodontics and Dentofacial Orthopedics at Government Dental College, Kozhikode.
This study is a randomized double blind, parallel group trial comparing efficacy of two treatment protocols for treating developing dentoskeletal class III corrections - SEA III and SEFA III.SEA III includes maxillary and mandibular splints, class III elastics, Alternate Rapid Maxillary Expansion and Constriction for 7 weeks. SEFA III protocol includes maxillary and mandibular splints, class III extra oral elastics, Alternate Rapid Maxillary Expansion and Constriction for 7 weeks and facemask for 14 - 16 hours. Primary outcomes are skeletal and dental dimensional changes in Class III patients following SEFA III protocol and a group of patients who had undergone SEA III protocol using conventional cephalometric analyses, standard reference points and planes at 1 year. Secondary outcomes are the soft tissue dimensional changes in Class III patients following SEFA III protocol and a group of patients who had undergone SEA III protocol using conventional cephalometric analyses, standard reference points and planes at 1 year.
Data will be computerized, and statistical analysis will be conducted using the Statistical Package for Social Sciences software for Windows. Quantitative variables will be summarized as mean and standard deviation. A paired and unpaired T test will be employed to compare the values before and after treatment(p>0.05).
If a significant result is observed in the SEA III group, the integration of the treatment protocol involving intra oral appliance alone may be considered for the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 9.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Deciduous or Mixed dentition 2)Angle’s Class III Molar relationship 3)Anterior Cross bite / Edge to edge 4)Wits appraisal of less than or equal to 2.0 mm and ANB less than or equal to 3 degrees 5) Skeletal maturation CS3 stage.
排除标准
- •Craniofacial malformations and/or syndromes 2)Previous orthopedic/orthodontic treatments.
结局指标
主要结局
primary outcome measures the skeletal and dental dimensional changes in Class III patients following SEFA III
时间窗: secondary outcome mesures the skeletal and dental dimensional changes in Class III patients following SEFA III | protocol and a group of patients who had undergone SEA III protocol using conventional | cephalometric analyses, standard reference points and planes at baseline(T1) and after 1 year(T2)
protocol and a group of patients who had undergone SEA III protocol using conventional
时间窗: secondary outcome mesures the skeletal and dental dimensional changes in Class III patients following SEFA III | protocol and a group of patients who had undergone SEA III protocol using conventional | cephalometric analyses, standard reference points and planes at baseline(T1) and after 1 year(T2)
cephalometric analyses, standard reference points and planes in 1 year.
时间窗: secondary outcome mesures the skeletal and dental dimensional changes in Class III patients following SEFA III | protocol and a group of patients who had undergone SEA III protocol using conventional | cephalometric analyses, standard reference points and planes at baseline(T1) and after 1 year(T2)
次要结局
- To compare the soft tissue dimensional changes in Class III patients following SEFA III(protocol and a group of patients who had undergone SEA III protocol using conventional)
研究者
Chelsia G Kulathinal
Government Dental College Calicut