Evaluation of Posterior Segment Intrusion Using Miniplates in Skeletal ClassII Hyperdivergent Adolescence: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 主要终点
- Lower facial height: the distance between soft tissue subnasale and gnathion (Sn.Gn) the difference will be measured in mm. before and after posterior segment intrusion
研究概览
简要总结
Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may be done by several methods as high pull headgear and posterior bite planes or surgically by maxillary impaction in adults. Nowadays it's the skeletal anchorage system (SAS) era as mini-screws and mini-plates ,hence we are aiming for absolute anchorage, and could minimize patient cooperation and the need for surgical treatment.
详细描述
Interventions:
A. Treatment group:
Medical History Questionnaire: will be filled by the patient to exclude the presence of any systemic condition.
Clinical Examination:
Oral structures will be examined by (M. N.) including Teeth for caries, fracture or missing teeth and gingival tissues for gingivitis, periodontitis, attachment loss, gingival recession, oral lesions and the nature of the gingival biotype.
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)
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild to moderate skeletal Class II
- •Super eruption of maxillary posterior segment
- •Erupted full set of maxillary permanent teeth except 3rd molar
- •Increased lower facial height
排除标准
- •Previous orthodontic treatment
- •Any hormonal disorders or syndromes
- •Systemic Disease
- •Facial Asymmetry
- •Para-functional habits
研究组 & 干预措施
Group 1
Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
干预措施: mini-plates supported molar intrusion (Device)
Group 1
Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
干预措施: Application of ULTRACARE benzocaine 20%, (Procedure)
Group 1
Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
干预措施: Administration of , Mepivacaine-l (Procedure)
Group 1
Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
干预措施: BETADINE povidone-iodine 10% (Procedure)
Group 1
Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
干预措施: (150g Clindamycin/tds) for 1 week (Drug)
Group 1
Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic
干预措施: (Cataflam 25mg), are prescribed post-operatively (Drug)
结局指标
主要结局
Lower facial height: the distance between soft tissue subnasale and gnathion (Sn.Gn) the difference will be measured in mm. before and after posterior segment intrusion
时间窗: 6 months
This measurement relates principally to the vertical dimensions of the upper dento-alveolar process and the mandible.
次要结局
未报告次要终点
研究者
Manal El Namrawy
assistant lecturer
Cairo University