Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in the Peri-implant Marginal Bone level
研究概览
简要总结
In this clinical trial the effect of the implant-abutment morphology (platform-switched vs platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard tissue (marginal bone loss) outcomes. Several clinical predictors (initial implant position level, gingival biotype, abutment height and prosthetic emergence profile) will also be taken into account as modulating factors of the clinical outcome.
详细描述
This prospective clinical trial is conducted at the Dental Clinic of the Faculty of Medicine of the University of Salamanca. The protocol was developed in accordance with the 1975 Declaration of Helsinki, and later approved by the Bioethics Committee of the University of Salamanca with the number (Ref:473/2020)
Before initiating any procedure, each patient received information about the study design and signed an informed consent. The subjects are recruited consecutively following the admission protocols of the Dental Clinic of the Faculty of Medicine of the University of Salamanca, Salamanca, Spain. The inclusion criteria are:
(1) Patients of legal age (>18 years); (2) in need of at least one maxillary or mandibular dental implant to be inserted in mature bone (more than 4 months after tooth extraction) in the posterior area (premolars and molars); (3) with good oral hygiene (plaque and gingival index ≤ 25%). The exclusion criteria included clinical conditions that contraindicated implant surgery, (1) patients with immunological alterations, pregnant and lactating, (2) heavy smokers > 20 cigarettes/day, (3) with the need for bone or soft tissue augmentations, (4) patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screwed restorations.
All implants were placed by an experienced implantologist following standard procedures and the manufacturer's recommendations. All implants were connected to a transmucosal abutment to heal in one-stage approach. Several variables were collected in this surgical phase (bone quality, implant stability, implant-bone level, mucosal thickness, keratinized mucosa width ...)
After 3 to 4 months of implant healing all the clinical parameters were reevaluated and the final impression will be used for the manufacturing of a porcelain-fused to metal screwed crowns.
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)
盲法说明
only the care provider knows the group asignement
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
- •Patients of legal age (>18 years).
- •With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars).
- •With good hygiene (plaque and gingival index ≤ 25%).
排除标准
- •Medical conditions that contraindicated implant surgery.
- •Patients with immunological alterations, pregnant and lactating.
- •Heavy smokers > 20 cigarettes/day,
- •Requiring bone augmentations or of soft tissues.
- •Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.
结局指标
主要结局
Change in the Peri-implant Marginal Bone level
时间窗: At baseline (reference), in comparison with 3, 6 and 12 months
The implant-bone level is assesssed radiographicly
Change in the Implant stablity quotient
时间窗: At baseline (reference), and in comparison with the 3 months follow-up
The ISQ is assesssed by Osstell
Change in the Gingival Thickness
时间窗: At baseline (reference) and in comparison with the 3, 6 and 12 months follow-up
The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper
次要结局
未报告次要终点
研究者
JAVIER MONTERO
Full Professor in Prosthodontics
University of Salamanca
