Assessment of the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One; A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- comparison of condylar volume of Herbst group versus TFBC group
研究概览
简要总结
This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint.
Study design:
Prospective randomized clinical study.
Study setting and population:
This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study.
Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion
详细描述
Participants will be selected based on the following inclusion criteria:
- Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°).
- Mandibular arch with minimum (up to 4mm) or no crowding.
- All permanent teeth are erupted (3rd molar not included).
- Good oral and general health.
- No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
- No previous orthodontic treatment.
outcomes measures:
- primary outcome: comparison of condylar volume of Herbst group versus TFBC group.
- secondary outcome: Measurement of of condylar volume within each group (Herbst group and TFBC group)
Treatment steps:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 20 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be selected based on the following inclusion criteria:
- •Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°). With agefrom 18 to 25 years.
- •Mandibular arch with minimum (up to 4mm) or no crowding.
- •All permanent teeth are erupted (3rd molar not included).
- •Good oral and general health.
- •No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
- •No previous orthodontic treatment.
排除标准
- •Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
- •Patients with untreated decay or any endodontic lesions.
结局指标
主要结局
comparison of condylar volume of Herbst group versus TFBC group
时间窗: nine months
three dimensional automatic measurement of condylar volume as one unit by Romexis software
次要结局
- Measurement of of condylar volume within each group (Herbst group and TFBC group)(nine months)
研究者
Mahmoud M. Fathy Aboelmahasen
Clinical professor of orthodontics - Faculty of dental medicine
Al-Azhar University