Comparative evaluation of Salivary Alkaline Phosphatase levels during single step vs two step mandibular advancement with Twin Block in growing children – A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To Assess and compare the levels of salivary alkaline phosphatase during single step vs two step advancement of mandible using twin block in growing skeletal class II children.
研究概览
简要总结
Class II functional appliances are indicated in the correction of mandibular deficiencies as they allow mandibular postural changes by holding the mandible forward and/or downward. The desired skeletal and dental changes during functional therapy can be attributed to various chemical markers of bone remodelling.Alkaline phosphatase is a known chemical biomarker of bone turnover during fixed and functional orthodontic treatment. The aim of the study is to assess the levels of salivary alkaline phosphatase during single step vs two step mandibular advancement with twin block in growing skeletal class II children.
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
- 11.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically No previous history of any orthodontic treatment.
- •Each subject with a full cusp class II relationship bilaterally with convex facial profile.
- •The overjet should be more than than 7 mm.
- •VTO improved with anterior positioning of mandible.
- •Radiographically: ANB angle more than 4 degrees with favourable growth pattern.
- •Subjects who are at accelerated phase of pubertal growth spurt (CVMI stage-3), MP3-FG and MP3- G stage.
排除标准
- •Syndromic cases.
- •Children with following disorders – A) Disorders of Bone metabolism.
- •B) Hepatobiliary disorders.
- •C) Systemic Inflammatory diseases.
- •Children with compromised oral hygiene.
- •Children taking drugs that can alter salivary flow.
结局指标
主要结局
To Assess and compare the levels of salivary alkaline phosphatase during single step vs two step advancement of mandible using twin block in growing skeletal class II children.
时间窗: Baseline salivary ALP levels prior to twin block delivery, 1 month, 2months, 3 months, 4 months, 5 months, 6 months
次要结局
- 1. Assess and compare skeletal and dentoalveolar effects of twin block therapy with a single step vs two step mandibular advancement.(2. Correlation of salivary alkaline phosphatase levels with skeletal effects.)
研究者
Priyanka Badu
Government Dental College and Hospital Nagpur