Canine Occlusal Relationship Changes After Full Mouth Rehabilitation and Stainless-Steel Crown Placement Under General Anesthesia in Group of Egyptian Children; Part 1: "Before and After Study".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in the canine occlusal relationship
研究概览
简要总结
The aim of the study is to Assess and compare canine occlusal relation in children with carious primary molars before they are treated by stainless steel crowns under general anaesthesia and after their placement, evaluate the possibility and the time required for the post-operative canine relation to resolve and how the treatment affects frequency and type of food intake.
详细描述
- The vertical overlap was determined after closing both arches in maximum intercuspation, intruding the tongue inwards away from the occlusal surfaces.
- After The patient had been anaesthetised, the measured values were recorded preoperatively and immediately after the treatment while the patient was unconscious.
- In order to achieve the maximum intercuspal position (MIP) at centric occlusion, it is recommended to gently push the tongue while using a metal spatula to close the patient's mouth.
- The distance between the gingival zenith from the upper to the lower deciduous canines was determined by the digital calliper in millimetres (Shenzhen Jiabaili Electronic Commerce Co., Ltd) at the right and left sides and a digital camera photographed the reading (iPhone 11 dual 12 MP Ultra-Wide and wide camera, Apple Inc.).
- The tooth is anesthetised, demineralised dentine will be removed, and if a pulpotomy or pulpectomy is needed (pulpotomy with Zinconol; Dentsply Sirona, Charlotte, NC, USA) and the subsequent restoration is with high-viscosity glass ionomer cement (GIC), The tooth will be prepared by occlusal, proximal reduction and; an SCC (3M™ ESPE™ Stainless Steel Primary Molar Crowns) will be tried and adjusted to fit the tooth. The size of the PMC that is tight enough to give a feeling of 'spring back' during seating should be selected. Occlusion is checked, and the SSC will be sealed with a GIC (CVI Fuji Plus; GC).
- Pre-operative determination of the vertical overlap of the upper and lower primary canines was done; after placement during the operation, four weeks, 2, and 6-month follow-up period.
- Tooth preparation was done according to the principles of Spedding *1 to have 1-mm clearance between the respective tooth and the opposing tooth, and SSCs (3M ESPE, St. Paul, MN, USA) were seated, and then the operator checked occlusion.
- After discharging the patient from the recovery room and re-establishment the function of the facial muscles, a questionnaire was taken from the parent assessing the preoperative state of the patient regarding pain and discomfort, swelling and type and frequency of food intake.
- As part of the measurement process, a single individual was responsible for capturing the readings while another person was documenting the results with a camera. This protocol was established to ensure accuracy and consistency in the results obtained and maintain a clear measurement record.
- Relief of symptoms and improvement of type and frequency of food intake were assessed by asking the parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical history: Normal healthy Egyptian children with no physical or mental disorders.
- •Gender: No sex predilection.
- •Age: Children from (2 to 6) years old show uncooperative behaviour.
- •Teeth: Carious teeth requiring oral dental rehabilitation under general requiring SSCs placement for primary molars.
- •Canine relationship class Ⅰ.
排除标准
- •Children with special health care needs or with systemic conditions.
- •Decayed primary canines with severe caries involving more than one-third of the incisal and palatal surfaces, class IV or V, crowns being built up or any incisal edge involvement.
- •Erupted permanent first molar.
- •Malocclusion i.e., Cross bite, Open bite.
- •Canine relation class Ⅱ, and Ⅲ
- •Parafunctional habits.
- •Refusal of participation.
研究组 & 干预措施
Patient's normal canine occlusal relationship
The distance between the gingival zenith from the upper to the lower deciduous canines was determined by the digital calliper in millimetres (Shenzhen Jiabaili Electronic Commerce Co., Ltd) (fig1,2,3) at the right and left sides and a digital camera photographed the reading (iPhone 11 dual 12 MP Ultra-Wide and wide camera, Apple Inc.).
干预措施: Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) (Device)
Canine occlusal relationship after full mouth rehabilitation
The distance between the gingival zenith from the upper to the lower deciduous canines was determined by the digital calliper in millimetres (Shenzhen Jiabaili Electronic Commerce Co., Ltd) (fig1,2,3) at the right and left sides and a digital camera photographed the reading (iPhone 11 dual 12 MP Ultra-Wide and wide camera, Apple Inc.).
干预措施: Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd) (Device)
结局指标
主要结局
Change in the canine occlusal relationship
时间窗: 6 months
The change in the canine occlusal relationship in millimeters using digital caliper
Change in the canine occlusal relationship
时间窗: Immediately
The change in the canine occlusal relationship in millimeters using digital caliper
Change in the canine occlusal relationship
时间窗: 4 weeks
The change in the canine occlusal relationship in millimeters using digital caliper
Change in the canine occlusal relationship
时间窗: 2 months
The change in the canine occlusal relationship in millimeters using digital caliper
次要结局
- The time needed for the bite to re-adapt("6 months")
- Child's proper masticatory function and discomfort(4 weeks)
- Child proper masticatory function and discomfort(6 months)
- The time needed for the bite to re-adapt("4 weeks")
- The time needed for the bite to re-adapt("2 months")
- Child proper masticatory function and discomfort(2 months)
研究者
Olaya Amr Moustafa Ez ElArab ElBahnacy
Principal Investigator
Cairo University