The Influence of Vertical Implant Position With Immediate Temporization on Marginal Bone Loss in Cases With Thin Soft Tissue Phenotype: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Marginal bone loss (crestal bone loss)
研究概览
简要总结
The goal of this clinical trial is to learn if vertical position of the dental implant will affect the bone around the implant in place of a missing tooth that happens to be bounded by two natural teeth. It will also measure esthetics and patient satisfaction. The main questions it aims to answer are:
Does vertical implant position below the crest of the bone lead to less marginal bone loss? Will it affect implant survival as well as quality of soft tissue, esthetics and patient satisfaction?
Participants will:
Have an implant placed at the bone level or 2 mm below the bone level Visit the clinic once every 3 months for checkups, radiographs, and readings
详细描述
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics (Degidi et al., 2011).
With respect to the depth of insertion, implants can be placed at various levels in the bone, which affects the peri-implant tissues with the surrounding marginal bone. Therefore, placement of an implant in a deeper position with respect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to maintain the peri-implant soft and hard tissues in comparison with crestal placement, though this affirmation is subject to controversy (Pellicer-Chover et al., 2019).
Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Each patient will be examined to confirm meeting the eligibility criteria. A full medical and dental history will be taken, and proper oral examination will be performed. Then a pre-operative cone beam computed tomography (CBCT) will be taken to examine both the bucco-lingual bone dimension and bone height and to ensure that the area of interest is free of any pathological lesions.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single missing upper anterior or premolar teeth
- •Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6 mm
- •Patients with thin soft tissue phenotype
- •Patients with healthy systemic conditions.
- •Patients older than 18 years.
- •Good oral hygiene.
- •Cooperative patients who accept a one-year follow-up period.
- •Patients who consent to being part of the study (sign an informed consent form).
- •Adequate inter-arch space for implant placement.
- •Favorable occlusion (no traumatic occlusion).
- •Absence of allergy to the prescribed medications.
排除标准
- •Patients with inadequate bone volume and/ or quality
- •Patients with local root remnants
- •Patients with inadequate wound healing
- •Patients with signs of acute infection related to the area of interest.
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- •Heavy smokers (more than 10 cigarettes per day) (Lambert, Morris and Ochi, 2000).
- •Metabolic diseases such as diabetes or hyperthyroidism as well as systemic medications such as chemotherapy or bisphosphonates
- •Pregnant or nursing women.
- •Uncooperative patients.
研究组 & 干预措施
Delayed implant with immediate temporization placed 2 mm subcrestal level
干预措施: Delayed implant with immediate temporization placed 2 mm subcrestal level (Procedure)
Delayed implant with immediate temporization placed at crestal bone level
干预措施: Delayed implant with immediate temporization placed at the crestal level (Procedure)
结局指标
主要结局
Marginal bone loss (crestal bone loss)
时间窗: Assessment at baseline, 3 months post-operative, 6 months post-operative, 9 months post-operative and 12 months post-operative
measured linearly in mm by comparing periapical radiographs
次要结局
- Midfacial recession(0, 3, 6, 9, 12 months post-operative)
- Pink Esthetic Score (PES)(baseline, 3, 6, 9, 12 months post-operative)
- Gingival thickness(baseline, 3, 6, 9, 12 months post-operative)
- Implant survival(12 months post-operative)
- Post-operative patient satisfaction(12 months post-operative)
- Radiographic horizontal bucco-palatal bone changes(baseline, 12 months post-operative)
- Radiographic vertical bone changes(baseline, 12 months post-operative)
- Emergence angle(baseline, 12 months)