Clinical and Radiographic Evaluation of Change in Labial Bone Thickness in Immediate Implant Placement In Maxillary Esthetic Zone Comparing a Jumping Gap of Less Than 2 mm to Equal or More Than 2 mm: A Non-randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Δ Labial bone thickness
研究概览
简要总结
The goal of this clinical trial is to assess the effect of distance between the implant and the bone on the resultant bone thickness adjacent to the implant in place of a broken down tooth that happens to be bounded by two natural teeth.
The main questions it aims to answer are:
Does the horizontal implant position (and hence the gap between the implant and the socket wall i.e. jumping gap) affect the resultant labial bone thickness? Will it affect the quality of soft tissue, esthetics and patient satisfaction?
Participants will have an implant placed using a surgical guide with a jumping gap either less than 2 mm or equal or more than 2 mm and will be asked to visit the clinic once every 3 months for checkups, radiographs, and readings.
详细描述
Tooth replacement with dental implants in the esthetic zone is often accompanied with esthetic complications such as mid-facial gingival recession, implant thread exposure and a concave contour. Various methods have been introduced to minimize the occurrence of such complications, including applying connective tissue grafts, grafting the jumping gap, performing immediate temporization and using surgical guides to ensure the placement of the implant in the optimal prosthetic position.(El Ebiary et al., 2023)
It would be beneficial to establish an evidence-based protocol for the jumping gap distance to follow through, with all immediate implants in the aesthetic zone, most of which have thin labial bone to begin with. Though there have been multiple studies conducted, specifically in the past few years, there is insufficient evidence that tells us what the optimal jumping gap is. (Hamilton et al., 2023) (Lambert et al., 2023).
Therefore, the aim of our study is to evaluate this survival rate and the amount of change in labial bone thickness that will result in different horizontal defect dimensions (HDD) ≤ 2 mm in comparison to the > 2 mm HDD.
The study will be conducted at the department of periodontology at the faculty of dentistry, Cairo University, Egypt. Patients will be selected from the outpatient clinic at the faculty of dentistry, Cairo University, Egypt. Patients screening will be carried out until the target sample is achieved.
Pre-operative phase:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a bounded single non-restorable upper tooth in the anterior maxilla (15-25) FDI (El Ebiary et al., 2023b)
- •Patients with an age range of 21 to 65 years old (Levine et al., 2022)
- •Patients with good oral hygiene with BoP ≤ 10 % (Chapple et al., 2018)
- •Compliant patients willing to follow up to one year.
- •Remaining labial bone thickness ≥ 1mm measured on C.B.C.T. and confirmed on the day of surgery after tooth extraction and before final implant placement.
排除标准
- •The presence of acute/active infection related to the non-restorable tooth (Block et al., 2009) cited in (Soegiantho et al., 2023)
- •Presence of labial bone defect as fenestration/dehiscence (Crespi et al., 2008) cited in (Soegiantho et al., 2023)
- •Large cyst or pathological lesion related to the tooth (Tallarico et al., 2016-2017) cited in (Soegiantho et al., 2023); (Morton, Wismeijer, Chen, Hamilton, Wittneben, Casentini, Gonzaga, Lazarin, Martin, Molinero-Mourelle, et al., 2023)
- •History of radiation to the maxilla (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)
- •History of bisphosphonate therapy or other anti-resorptive agents (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)
- •Uncontrolled systemic or metabolic disease. (Cecchinato et al., 2015) cited in (Soegiantho et al., 2023)
- •Patients with parafunctional habits or active periodontitis (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023) 8- Tobacco abuse (>10 cigarettes per day) (Canullo et al., 2010) cited in (Soegiantho et al., 2023)
- •9- Alcohol abuse (Block et al., 2009) cited in (Soegiantho et al., 2023)
研究组 & 干预措施
Immediate implant placement with jumping gap less than 2 mm
surgically guided placement of a single immediate post-extraction implant in the upper aesthetic zone with a jumping gap < 2 mm.
干预措施: Immediate implant placement with jumping gap less than 2 mm (Procedure)
Immediate implant placement with jumping gap equal to or more than 2 mm
surgically guided placement of a single immediate post-extraction implant in the upper esthetic zone with a jumping gap ≥ 2mm.
干预措施: Immediate implant placement with jumping gap equal to or more than 2 mm (Procedure)
结局指标
主要结局
Δ Labial bone thickness
时间窗: Assessment at baseline and after 12 months.
It will be measured virtually using CBCT measurements, fusion of the C.B.C.Ts will be done.
次要结局
- Jumping gap (accuracy)(Before implant placement and immediately after.)
- Crestal Bone Level(Assessment at baseline, 3 months, 6 months, 9 months and 12 months.)
- Pink Esthetic Score(Assessment after final crown delivery (baseline), 3 months, 6 months, 9 months and 12 months.)
- Patient satisfaction(One time at 12 months after crown delivery.)
- Keratinized soft tissue width(Assessment will be at the surgery day (baseline), 3 months, 6 months, 9 months and 12 months after crown delivery.)
- Keratinized soft tissue thickness(Assessment will be at the surgery day (baseline), 3 months, 6 months, 9 months and 12 months after crown delivery.)
研究者
Isaac Essam Awad Bastawros
Dr.
Cairo University