跳至主要内容
临床试验/NCT07310979
NCT07310979Enrolling By Invitation不适用

Biomechanical and Clinical Effects of a Hyperbolic Paraboloid Triple-Abutment System on Morse Taper Dental Implants: Prospective Clinical Study With Finite Element Corroboration

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月29日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Changes in Marginal Bone Level (mm)

研究概览

简要总结

This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a novel triple-abutment system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The system is designed to support three adjacent crowns on a single implant, aiming to optimize load distribution and preserve peri-implant tissue stability.

Thirty systemically healthy adults missing three adjacent teeth will undergo implant placement, followed by a healing period of approximately three months for osseointegration prior to prosthetic loading. Metal-ceramic restorations will then be cemented over triple abutments. Clinical and radiographic evaluations will be performed at T1 (3-4 months after prosthetic loading) and T2 (12-18 months after prosthetic loading).

The primary outcome will be marginal bone level change assessed by standardized periapical radiographs. Secondary outcomes include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction. The study aims to investigate whether this innovative abutment design provides stable peri-implant conditions and favorable clinical performance when applied to Morse taper implants.

详细描述

This prospective clinical study aims to evaluate the clinical and radiographic performance of an innovative triple-abutment (TA) system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The abutment system is designed to support three adjacent crowns on a single implant through a fully curved, passive, non-welded configuration, with the objective of optimizing biomechanical load distribution and preserving peri-implant tissue stability. The concept is based on principles of mechanobiology, mechanotransduction, and biotensegrity, integrated within the framework of Optimized Biodynamic Peri-Implant Tissue (BOPiT).

Thirty systemically healthy adult participants presenting with three adjacent missing teeth will be enrolled. Implant placement will be performed following conventional surgical protocols. After surgery, a healing period of approximately three months will be allowed to achieve osseointegration prior to prosthetic loading. Subsequently, metal-ceramic fixed prostheses will be cemented over triple-abutment components. All surgical and prosthetic procedures will be conducted by a single experienced operator to ensure standardization.

Clinical and radiographic evaluations will be performed at two predefined follow-up timepoints: T1, corresponding to 3-4 months after prosthetic loading, and T2, corresponding to 12-18 months after prosthetic loading. The primary outcome measure will be marginal bone level change, assessed on standardized periapical radiographs obtained using the parallel technique with controlled calibration, and measured at the mesial and distal aspects of each implant.

Secondary outcome measures will include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction assessed using a visual analog scale (VAS). Clinical maintenance visits will be scheduled every four months between T1 and T2 to monitor peri-implant health and prosthetic performance.

Statistical analyses will be conducted using parametric methods appropriate for repeated measures, with strategies to account for potential within-subject correlation in participants receiving more than one implant. Adverse events and biological or prosthetic complications will be recorded throughout the study period. The risks associated with participation are minimal and comparable to those of conventional implant-supported rehabilitations. In the event of complications, the triple-abutment system may be replaced by conventional abutments according to clinical judgment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Adults aged ≥ 18 years.
  • Systemically healthy as determined by medical history and clinical assessment.
  • Non-smokers (no tobacco use).
  • Able and willing to comply with study visits and maintenance program, and provide written informed consent.

排除标准

  • diabetes mellitus (any type) or uncontrolled systemic disease.
  • current or recent tobacco/nicotine use
  • bisphosphonates or other antiresorptives,
  • immunosuppressive therapy,
  • osteoporosis
  • pregnancy or lactation.

结局指标

主要结局

Changes in Marginal Bone Level (mm)

时间窗: baseline vs. 3 months

Marginal bone level measured in millimeters at the mesial and distal aspects of each implant using standardized periapical radiographs with the parallel technique and calibrated measurements, assessed at T1 (3-4 months)

次要结局

  • Changes in Peri-Implant Probing Depth(baseline versus 12-18 months (T2) after prosthetic loading)
  • Presence of dental plaque(baseline versus 12-18 months (T2) after prosthetic loading)
  • Changes in Keratinized Mucosa Height(baseline versus 12-18 months (T2) after prosthetic loading)
  • Changes in Marginal Bone Level (mm)(baseline vs. 12-18 months after prosthetic loading)
  • Level of Patient Satisfaction(baseline versus 12-18 months (T2) after prosthetic loading)
  • Presence of Bleeding on Probing(baseline versus 12-18 months (T2) after prosthetic loading)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando O Costa

Titular professor

Federal University of Minas Gerais

研究点 (1)

Loading locations...

相似试验