Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Radiographic width of bone labial to the implant
研究概览
简要总结
Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft 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 tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft 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
sticky tooth preparation:
- patient's venous blood will be collected using a 21 g needle with a butterfly handle.
- The blood in the test tubes will be centrifuged at 700 rpm for 3 min for women and 4 min for men because of a different hematocrit.
- The liquid PRF fraction will be collected using a sterile syringe. It gently will be mixed with the demineralized dentin granules and allowed for five-ten minutes for polymerization in order to produce a sticky tooth.
干预措施: immediate implant augmented with sticky tooth (Procedure)
Control group
Autogenous demineralized dentin graft preparation
- Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation.
- The pulp will be removed, using a root canal instrument. Subsequently, the remaining dentin will be cut into pieces. These pieces of dentin will be ground using a bone mill to produce dentin particles.
- The sorted particles will be immersed in 70% ethanol and 4% H2O2 in a sterile container to remove any soft tissue remnants, bacteria, and smear layer.
- Tooth particles will be demineralized using 0.6N HCl for 30 minutes to expose the dentine organic matrix.
- After demineralization, the materials will be washed with phosphate-buffered saline (PBS) and dried with sterile gauze.
干预措施: immediate implant augmented with autogenous tooth graft (Procedure)
结局指标
主要结局
Radiographic width of bone labial to the implant
时间窗: 1 year
Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times
次要结局
- Width of the Keratinized Tissue(1 year)
- Implant stability(6 months)
- Radiographic vertical bone changes(1 year)
- Midfacial recession(1 year)
- Gingival Thickness(1 year)
- Radiographic horizontal bucco-palatal bone changes(1 year)
- Esthetic evaluation (The pink esthetic score)(1 year)
- Post-Operative Pain(7 days)
- Post-Operative patient's Satisfaction(1 year)
- Post-operative swelling(7 days)
研究者
Halla Gamal Mohammed Esmail
Dentist
Cairo University