Clinical Evaluation of a New Colour Changing Orthodontic Adhesive Orthofix Pro Versus Conventional Orthodontic Adhesive Enlight V: In Vivo Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V.
研究概览
简要总结
This study is a randomized , participant blinded , parallel group, active controlled trial, comparing the clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V in 24 patients that will be conducted in Hitkarini dental college and Hospital ,Jabalpur ,Madhya Pradesh, India. The primary outcome measures will be clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V over a six-month period . The secondary outcomes will be the orthodontic bracket failure rates with respect to patient’s gender, type of tooth, type of quadrant, arch and position of tooth (anterior and posterior) and to determine the mode of bracket failure according to adhesive remnant index (ARI) at every consecutive month over a six-month period**.**
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 Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Complete permanent dentition.
- •Patient requiring fixed appliance therapy in both arches.
- •Both extraction and non-extraction cases.
- •No history of active or previousorthodontic treatment.
- •No hypoplastic lesion in enamel.
- •Good oral hygiene.
排除标准
- •Patient with congenital enamel defects.
- •Patient with missing tooth.
- •Patient with craniofacial anomalies.
- •Patient who requires orthognathic surgical treatment.
- •Patient who presents with traumatic occlusion.
结局指标
主要结局
clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V.
时间窗: 6 Months
次要结局
- To determine the mode of bracket failure according to adhesive remnant index (ARI)(6 Months)
- To determine the in-vivo orthodontic bracket failure rates with respect to patient’s gender, type of tooth, type of quadrant, arch and position of tooth (anterior and posterior)(6 Months)
研究者
Dr Priya Kumari
Hitkarini Dental College and Hospital