Comparative evaluation of nasal and alveolar changes in complete unilateral cleft lip and palate patient using Intraoral and Extraoral nasoalveolar molding technique.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intra alveolar cleft width, total alar base width,collumellar length
研究概览
简要总结
Cleft lip and palate is the most common congenital anomaly of craniofacial region.Infants born with unilateral cleft lip and palate have characteristic signs like nasal asymmetry due to a shortened columella, displaced alar base, asymmetric and displaced nostril tip and missing nasal floor.Surgeons all over the world tried to improve the aesthetic outcome of this disorder after surgery but the results are unsatisfactory. Nasoalveolar molding (NAM)plays a significant role to improves the aesthetic and functional aspects of nose and maxilla before surgery. It consists of an intraoral molding plate with nasal stent (Intraoral NAM technique) to mold the alveolar ridge and nasal cartilage concurrently.The objective of the NAM is to reduce the severity of the original cleft deformity and thereby significantly improve the surgical outcome of primary lip repair.However for the patient living in remote area where the facilities are not readily available it is difficult for parents to visit the hospital frequently for weekly activation of NAM plate. This makes NAM a poor choice for cleft lip and palate patient due to poor compliance..Cases have been reported in the literature showing NAM technique done by using adhesive lip tapping and nasal stent (Extraoral NAM technique). Adhesive lip tapping with nasal stent alone can decrease the gaps between alveolar segment and tension of the lip and also nasal stent is activated once in a month. Therefore the overall cost is reduced and compliance of both patient and parent is improved.But till date no comparative studies have been reported in the literature showing the efficiency of Extraoral nasoalveolar molding technique. With this background the present study is planned to evaluate nasal and alveolar changes in complete unilateral cleft lip and palate infants ( both right and left side ) using Intraoral and Extraoral NAM technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Infants below 7 days of age.
- •All non-syndromic Infants.
- •Infants not associated with any systemic illness.
- •Moderately to well nourished healthy Infants.
排除标准
- •Infants above 7 days of age.
- •Syndromic, malnourished and systemically ill Infants.
- •Guardians who will be unwilling to go through the NAM therapy.
- •Isolated cleft palate, cleft lip and bilateral cleft lip and palate cases.
- •All unoperated unilateral cleft lip and palate cases.
结局指标
主要结局
Intra alveolar cleft width, total alar base width,collumellar length
时间窗: Baseline- 7 days | Post treatment - 3 month
次要结局
- Nostril height, nostril width (cleft side and non cleft side)(Base line - 7 days)