Evaluation of Soft and Hard Tissue Changes Following Immediate Implant Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Bucco/facial-palatal ridge thickness
研究概览
简要总结
: Evaluation of Soft and Hard Tissue Changes following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique for management of Cases With Labial Plate Dehiscence
详细描述
In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-restorable teeth in the esthetic zone with a defect of labial bone.
- •Teeth with no acute inflammation.
- •Patients are free from any systemic condition that may affect the healing.
- •Availability of bone apical and palatal to the socket to provide primary stability
- •Good oral health.
- •Willingness to sign the informed consent form.
排除标准
- •Heavy smoker (> 10 cigarettes/day)
- •Pregnant females
- •Contraindication for Implant surgery.
- •Patients with poor oral hygiene.
- •Acute inflammation in the site of implantation and adjacent tissue.
- •A history of radiotherapy in the head or neck region.
- •Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation
研究组 & 干预措施
Intervention group Immediate Dentoalveolar Restoration
- After applying anesthesia to the maxillary tuberosity, a full thickness crestal incision was made following the distal contour of the maxillary right second molar. This incision was followed by a palatal release incision to access the donor area.
- The flap was raised in the tuberosity area Then, the bone graft was harvested from the underlying bone by using a 1 cm wide flat chisel and a surgical hammer.
- The corticocancellous graft was manipulated using a rongeur to reproduce the shape of the peri-implant bone defect.
- The graft was carefully inserted to the level of the implant platform Finally, a screw-retained resin provisional crown, relined over a polyetheretherketone (PEEK) anti-rotation abutment, was placed out of occlusion, establishing the ideal emergence profile to accommodate the soft tissues and to promote a thicker and more stable gingival tissue margin
干预措施: Immediate Dentoalveolar Restoration (Procedure)
Control group Ice cream cone technique
Ice cream cone technique
- Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone.
- The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.
The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using resorbable sutures to prevent dislodgment of the blood clot and bone grafting material
干预措施: Ice cream cone technique (Procedure)
结局指标
主要结局
Bucco/facial-palatal ridge thickness
时间窗: 1 year
Impressions were taken with addition silicone before tooth extraction, after six months of implant placement (immediately after the placement of the definite crown) and 12 months after crown installation. Casts were then obtained with special gypsum stone type IV.Casts were measured by a dentist not involved in the study with a digital caliper. Three reference points were measured from the free gingival margin to the apex at the implant site and in the contralateral tooth: 0 mm, 3 mm and 6 mm
次要结局
- Gingival Thickness(1 year)
- Post-Operative Pain(7 days)
- Width of the Keratinized Tissue(1 year)
- Radiographic bucco-palatal bone changes(1 year)
- Radiographic vertical bone changes(1 year)
- 3. Radiographic width of bone labial to the implant(1 year)
- Implant stability(6 months)
- Midfacial recession(1 year)
- Post-Operative patient's Satisfaction(1 year)
- Esthetic evaluation (The pink esthetic score)(1 year)
- Post-operative swelling(7 days)
研究者
Aya Sharaf
Dentist
Cairo University