跳至主要内容
临床试验/NCT07526337
NCT07526337招募中不适用

Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
peri-implant marginal bone remodeling (mm)

研究概览

简要总结

Maxillary posterior area is the most challenging site for dental implant placement. Indeed, complex remodeling processes, resulting in changes of the maxillary sinus and shape of the alveolar ridge will cause difficulties in rehabilitating the posterior maxillae sites. Various techniques have been proposed in order to achieve the necessary bone volume for the placement of long term successful implants. However, unbalanced crown to implant ratio remains a risk factor after successful dental implants installation following sinus graft. No study on humans assessed the effect of apical positioning of the implants in posterior grafted sites (sinus graft or sinus graft + vertical GBR) on the following clinical parameters: The peri-implant bone remodeling (vertical bone loss (mm) and probing depth (mm) around the implants, crown bulkiness, emergence profile and crown height, and Patients satisfaction, food impaction (PROM)).

This study will elucidate these points and based on the parameter's results, suggest a treatment based classification facilitating the treatment decision-making of the clinicians in case of an atrophic posterior maxilla; aiming to ensure a long-term successful supra-implant rehabilitation which will maintain its bio-mechanically and biological success.

详细描述

  1. INSTITUTION Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University of Beirut, Beirut, Lebanon Cranio-Facial Research Laboratory, Faculty of Dental Medicine, Saint Joseph University of Beirut, Beirut, Lebanon.
  2. TYPE OF PROJECT Master's degree in periodontology
  3. PROJECT TITLE Digital planning and clinical assessment of the treated atrophic posterior maxilla with a sinus lift procedure: a cross-sectional study.
  4. RESEARCH AND PUBLICATION TEAM

Director:

Pr. Nadim Mokbel, DDS, MSc, PhD Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University of Beirut, Beirut, Lebanon Nadim.mokbel@gmail.com

Co-director:

Dr. Abdel Rahman Kassir, DDS, MSc Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University of Beirut, Beirut, Lebanon Kassirabdelrahman@gmail.com

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Patient aged more than 18 years.
  • Partially edentulous patients having an implant rehabilitation treated with a sinus lift procedure in the atrophic posterior maxilla.
  • Patient with no systemic disease that contraindicate the surgical procedure as uncontrolled diabetes mellitus, bleeding disorders, recent myocardial infarction, head and neck radiation, and mental disorders.

排除标准

  • - Fully Edentulous patients.
  • Patients presenting sinus pathologies (sinusitis, thickening of the membrane).
  • Patient smoking more than 20 cigarettes.
  • Patient taking systemic drugs that could affect bone healing as immune suppressive drugs and bisphosphonates.
  • Patient with systemic disease that contraindicate the surgical procedure as uncontrolled diabetes mellitus, bleeding disorders, recent myocardial infarction, head and neck radiation, and mental disorders.

研究组 & 干预措施

1

partially edentulous patients having an implant rehabilitation treated with a sinus lift procedure in the atrophic posterior maxilla

结局指标

主要结局

peri-implant marginal bone remodeling (mm)

时间窗: 3 years

Recorded at the mesial and distal aspect of each implant. The distance from the implant-abutment interface to the first bone-to-implant contact (bone level) was assessed on peri-apical radiographs taken with the long cone paralleling technique that were taken during the recall visits (after implant loading). Bone Level values were calibrated according to the actual implant length, following the next formula, according to Chen et al. 2023: (99) The BL was measured at the mesial (M) and distal (D) aspects of each implant at baseline (initial bone level, IBL) and follow-up (final bone level, FBL). The change in MBL was calculated as the difference between the mean FBL and mean IBL. The following formulas were used: (99).

- Pocket probing depth (mm).

时间窗: 1 week

is measured with the periodontal probe Hu-Friedy Periodontal Probe PCP UNC15 (Hu-Friedy, Chicago, Illinois), going parallel to the axis of the implant to the nearest 0.5 mm, at 6 different sites per implant (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, distopalatal)

- Bleeding on probing.

时间窗: 1 week

analyzed 15 seconds following pocket probing around 6 sites per implant.

次要结局

  • - Keratinized tissue width (mm).(1 week)
  • - Crown-to-implant ratio(1 week)
  • - Crown height and diameter(1 week)
  • - Emergence angle (supra-implant crown bulkiness and height)(1 week)
  • patient reported outcome measures (PROMs)(1 week)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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