Evaluation of 3D Printed Modified Twin Block Appliance for Correction of Skeletal Class II Malocclusion in Growing Subjects: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Skeletal Class II profile correction
研究概览
简要总结
The study is to evaluate the effect of 3D printed modified Twin Block Appliance on skeletal Class II profile correction.
The null hypothesis of this research is that use of 3D Printed Twin Block is not able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with untreated growing Class II control subjects.
详细描述
I- For the treatment group:
A- Medical History Questionnaire will be filled by the patient to exclude the presence of any systemic condition.
B- Clinical Examination:
Proper examination of the oral structures including;
- Teeth will be examined for caries, fracture or missing teeth
- Gingival tissues will be examined for gingivitis, periodontitis, attachment loss, gingival recession, oral lesions and the nature of the gingival biotype.
- Thorough intraoral examination is needed to evaluate the need for referral for consultation or intervention before the initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient and the of the pre and post treatment radiographs used for analysis.
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 10-13 years of age.
- •Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
- •Horizontal or neutral growth pattern. (MMP ≤ 30°)
- •Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
- •Cervical Vertebral Maturation (CVM) stage 3.
排除标准
- •Systemic Disease.
- •Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
- •Extracted or missing upper permanent tooth/teeth (except for third molars).
- •Facial Asymmetry.
- •Para-functional habits.
- •Severe proclination or crowding that requires extractions in the lower arch.
结局指标
主要结局
Skeletal Class II profile correction
时间窗: 8months
A-Effective mandibular length in mm B- SNB in degrees using lateral cephalogram
次要结局
- Soft tissue convexity correction(8 months)
- Inclination of anterior teeth(8 months)
- Patient acceptance(8 months)
研究者
: Donia Ayman Ahmed Ezzeldin ElSayed
Master degree student
Cairo University