Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Bite correction of digitized models.
研究概览
简要总结
Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or underbites following early cleft repair surgeries. This clinical trial compares the current standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after pubertal growth (16-21 years), with an alternative orthopedic approach to protract the maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". Prior to age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective parallel cohort study will assess the patients undergoing treatment for the Cl III malocclusion by either orthognathic surgery or maxillary protraction at four data collection time points during treatment. The data includes digitized study models, photographs and radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost, periodontal measurements and treatment complications. The study design is a descriptive cohort study that examines the success of treatment (% not requiring a second surgery), the dental and skeletal changes associated with treatment, the stability of treatment and the behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a pilot study to confirm translation to different settings will be conducted at Seattle Children's Hospital.
详细描述
Rationale: Cleft lip and palate is the most common facial birth defect. Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusion or underbites for which the current standard of care to treat the Cl III malocclusion is orthognathic (jaw) surgery. Orthognathic surgery is performed late in a teenager's life after pubertal growth is complete, has a long recovery period, has risks for segment loss and nerve injury and is expensive to the insurers. Moreover, the surgical correction can relapse and require a second jaw surgery.
Intervention: The current standard of care for correcting a Cl III malocclusion is orthognathic surgery after pubertal growth is complete. At Children's Hospital, early adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) in order to correct the underbite.
Purpose: This study will compare the occlusal, photographic, radiographic, periodontal and quality of life data collected at four different timepoints from patients who were treated for the correction of their Cl III malocclusion by either LeFort I maxillary advancement surgery or non-surgical maxillary protraction.
Study Population: The inclusion criteria are patients who are diagnosed with isolated cleft lip and palate with Cl III malocclusion and who, at the time of enrollment, do not have any medical condition which will prevent them from undergoing orthognathic surgery or maxillary protraction procedures. The two study groups differ in age and treatment. One group of patients, ages 11 -14 years of age, chose to undergo maxillary protraction via sutural loosening for correction of Cl III malocclusion. The other group of patients, ages 16 and 21 years, elected to undergo orthognathic surgery for correction of Cl III malocclusion.
Study Methodology: This is a non-randomized prospective parallel cohort study that follows the treatment outcomes of approximately 100 patients with cleft lip and palate and Cl III malocclusion who are treated with maxillary protraction at about a maximal age of 14 years (target N=50) vs. orthognathic surgery at a maximal age of 21 years (target N=50).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of nonsyndromic cleft lip and palate and Class III malocclusion
- •Age 11-14 for maxillary protraction, Age 16-21 for LeFort I single jaw surgery.
排除标准
- •Cognitive delay;
- •Mandibular asymmetry;
- •Mandibular prognathism;
- •2-jaw cants;
- •Non-grafted alveolar cleft;
- •Inability or unwillingness to have clinical radiographs, photographs, or dental impressions taken;
- •History of therapeeutic radiation treatment to the mazilla or mandible;
- •Pregnancy; if participants become pregnant during the study they will be withdrawn.
结局指标
主要结局
Bite correction of digitized models.
时间窗: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
The metric for comparing the difference in bite using study models from patients with cleft lip and palate is the "GOSLON Yardstick" which can rate antero-posterior as well as transverse positions.
次要结局
- Facial attractive rating of photographs(The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
- Costs of treatments(At the end of approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
- 12-Item Short Form Health Survey (SF-12) developed by the Rand Corporation(The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
- Youth Quality of Life (YQOL) survey designed by the Seattle Quality of Life Group(The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
- Achenbach System of Empirically Based Assessment (ASEBA)(The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
- Periodontal measurements(Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
- Cephalometric radiographs(The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.)
研究者
Stephen Yen
Associate Professor
University of Southern California