Evaluation of Bone-borne Palatal Expander in Conjunction With Maxillary Osteotomy in the Treatment of Cleft Palate Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Adequate maxillary expansion
研究概览
简要总结
The tooth-borne palatal expander has limitations in the subset of patients with scarred, constricted cleft palate. At times, although posterior expansion is successful, transverse expansion of the anterior palate (near the alveolar cleft) is inadequate.
Will the application of bone borne palatal expander combined with a corticotomy be more effective in the expansion of the constricted maxilla in cleft palate patients?
详细描述
Intervention:
Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae for previously treated cleft palate patients.
o Preoperative Preparations: All data of the patient will be gathered including personal data, medical history, family history, and classification of palatal cleft will be registered;
- Laboratory investigations will be conducted (CBC, coagulation profile, weight). -Models from dental impressions are made to make standardized measurements which include:-
- IMD: distance between two lingual grooves of two opposing first molars
- ICD: distance between cusp tip if two opposing canines
- Alveolar cleft width
- Total palatal area
- The correct distractor module can be measured bone to bone with the fitting models to choose the distractor length.
o General operative procedures
- The procedures will be performed under general anesthesia with nasotracheal intubation.
- Local anaesthesia with vasoconstriction Epinephrine 1:100:000 will be injected in the palatal mucosa and mucolabial fold.
- The palatal incision is done between the premolar and molar or between the premolars.
- Maxillary vestibular incision followed by lateral corticotomy.
- Placement of distractor plates horizontally and fixing it with self-drilling screws between two roots on each side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with non-syndromic cleft palate.
- •Patients with constricted maxilla after surgical treatment of cleft palate.
- •Patients failed orthodontic expansion.
- •Patients age between 8 and 18 years.
排除标准
- •Patients with systemic disease or bleeding disorders.
- •Patients with syndromic cleft palate.
- •Patients failed with tooth borne expansion.
- •Patients with fistula in cleft palate
结局指标
主要结局
Adequate maxillary expansion
时间窗: 10-12 weeks post operatively
Dental casts before treatment \& immediately after completion of expansion to determine transverse changes in maxillary arch width measured in millimeter at the following sites: Intermolar width Intercanine width Interarch width 6 CBCT before operation \& immediately after completion of consolidation period (10 weeks). Distances measured on the coronal images in millimeters before treatment \& after the end of the consolidation period: NFW4 \& NFW6: Nasal floor width at the area of first premolars \& first molars, 5mm above the most inferior part of nasal floor PBW4 \& PBW6 : Palatal bone width at the level of a line connecting palatal root apex of first premolars \& first molars IRD4: distance between palatal root apex of right \& left first premolars IRD6: distance between palatal root apex of right \& left first molars
次要结局
未报告次要终点
研究者
Sarah Ahmed Sameh
Principal Investigator
Cairo University