Peri-implant Soft Tissue and Bone Evaluation of One Abutment One Time Concept Following Fully Computer Guided Immediate Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- peri-implant soft tissue volumetric change
研究概览
简要总结
Prospective evaluation of perimplant soft tissue and bone response to one abutment one-time concept versus provisional abutment in fully guided single immediate implant placement.
详细描述
Patient selection:
The study will be conducted on total of 16 patients recruited from the outpatient clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dentistry, Ain-Shams University. Sixteen consecutive healthy male/female patients with single non restorable remaining maxillary root from the right second premolar to the left second premolar will be added to the study.
Sample size analysis :
A sample size of 14 (7 in each group) will be sufficient to detect an effect size of approximately 1.75, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data. G power program version 3.1.9.2 was used for sample size calculation.This was increased to 8 patients in each group to make up for lost follow up cases The procedure will be explained to all patients and an informed consent will be signed before their inclusion in the study.
These patients will be divided randomly into 2 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged at least 18 years.
- •Patients free from any systemic disease as evidenced by health questionnaire - - Single tooth failure of a maxillary anterior region (incisors, canines, and premolars) with neighbouring teeth present and healthy periodontal conditions.
- •Intact socket walls evident on cone beam computed tomography and confirmed on the day of extraction.
- •Natural teeth present adjacent to the tooth being replaced in addition to a natural counterpart tooth present for esthetics criteria evaluation.
- •Adequate bone apical to the tooth to be replaced with a minimum primary stability of 30 Ncm.
- •Thick gingival biotype.
排除标准
- •Presence of active infection around the failing tooth or adjacent teeth.
- •Presence of active periodontal disease and gingival recession in the esthetic area.
- •Systemic diseases , pregnancy and smoking.
- •Recent orthodontic treatment.
- •Bruxism and parafunctional habits .
- •Labial plate dehiscence, fenestration, or loss after tooth extraction
- •Inability to achieve primary stability after implant placement
- •Vulnerable groups: prisoners, mentally retarded, etc
研究组 & 干预措施
immediate load with provisional restoration
immediate load with PMMA crown on Ti base
干预措施: guided immediate implant surgery (Procedure)
immediate load with one abutment one time concept
immediate ;load with customized final abutment and PMMA crown
干预措施: guided immediate implant surgery (Procedure)
结局指标
主要结局
peri-implant soft tissue volumetric change
时间窗: 4 months
* intraoral scanner is used to obtain before and after 3D scans * 3D scans are superimposed on a software and the difference in volume can be measured and detected by a color map
次要结局
- Esthetic evaluation(4 months)
研究者
Nouran Abd El Nasser
Assistant lecturer
Ain Shams University