NCT06040788尚未招募不适用
Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment. A 1-Year Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Amount of labiopalatal ridge collapse
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of different anatomical variations in terms of root angulation, alveolar bone and basal bone morphology on soft and hard tissue alterations in patients with non-restorable teeth in the inter-canine region undergoing immediate implantation. The main question it aims to answer are:
- Will the amount of collapse be greater when the root is proclined or outside the bone housing?
- Will no additional intervention be needed with immediate implants in the esthetic zone if we have better anatomy that will help hinder the collapse? Participants will receive immediate dental implants with customized healing abutments
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient-related criteria:
- •Adults at or above the age of
- •Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant placing therapy.
- •The failing tooth will have adjacent and opposing natural teeth.
- •Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- •Able to tolerate surgical periodontal procedures.
- •Good oral hygiene.
- •Compliance with the maintenance program.
- •Provide informed consent.
- •Accepts the one-year follow-up period.
- •Teeth related criteria:
- •Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- •Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
- •Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm.
排除标准
- •Patients diagnosed with periodontal diseases.
- •Current or previous smokers.
- •Pregnant and lactating females.
- •Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- •Patients with active infection related at the site of implant/bone graft placement.
- •Patients with parafunctional habits
研究组 & 干预措施
immediate implant placement with customized healing abutment
Experimental
干预措施: immediate implant placement with customized healing abutment (Procedure)
结局指标
主要结局
Amount of labiopalatal ridge collapse
时间窗: 1 year
radiographic Labiopalatal ridge collapse via CBCT
Amount of bone labial to the implant
时间窗: 1 year
Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT
次要结局
- Amount of vertical crestal bone resorption in millimeters(1 year)
- Amount of change in buccal soft issue contour in mm3(1 year)
- amount of Mid facial recession in millimeters(1 year)
- Pink esthetic score(1 year)
研究者
Nesma Mohamed Fouad Shemais
Lecturer in the department of Oral Medicine & Periodontology
Cairo University
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