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临床试验/NCT07760064
NCT07760064已完成不适用

Assessment of Peri-implant Tissue Behavior, Pink Esthetic Score, Patient Satisfaction and Marginal Accuracy Associated With Biologically Oriented Preparation Technique for Implant Supported Crowns

Kholoud Mohamed Mahmoud Soliman1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
marginal discrepancy

研究概览

简要总结

patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment teeth in the BOPT protocol

Construction of the crowns:

Patients in both groups will receive porcelain fused to metal crowns.

Assessment of:

Soft tissue thickness Hard tissue thickness Marginal discrepancy Pink esthetic score Patient satifaction

详细描述

Armamentarium:

To conduct the present study, the following will be used:

  1. Conventional titanium abutments
  2. Biologically oriented prepared titanium abutments
  3. Dental implants
  4. Intra oral scanner software

Methodology:

  1. Sample size calculation:

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
Single (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range of patients 20-45 years old, with no gender prediction, able to read and sign the informed consent.
  • •2. Patient with missing tooth in the esthetic region indicated for replacement with implant.
  • •3. Adjacent and opposing natural teeth should be present.
  • •The edentulous ridge should be free from any infection or remining root.
  • •Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically.
  • •6. Patient should be willing to return for follow-up examination and evaluation.

排除标准

  • •- Patients with active periodontal diseases.
  • •Patient with poor oral hygiene and motivation.
  • •Pregnant women.
  • •Patient with unrealistic expectations.
  • •Patients with parafunctional habits and smoker.
  • •Patient with systemic disease and immunocompromised patients which will prevent surgical procedure.
  • •7. Recent extraction or extraction socket with infection or remaining root.

研究组 & 干预措施

conventional shoulder abutment

Active Comparator

customized zirconia shoulder implant abutment with screw retained zirconia crown will be fabricated

干预措施: customized biologically oriented prepared implant abutment (Procedure)

customized biologically oriented prepared implant abutments

Active Comparator

customized zirconia shoulderless implant abutment with screw retained zirconia crown will be fabricated

干预措施: customized biologically oriented prepared implant abutment (Procedure)

结局指标

主要结局

marginal discrepancy

时间窗: at delivery time

by dual scan replica technique

soft and hard tissue thickness

时间窗: 3,6 and 9 moths

by cone beam ct

pink esthetic score and patient satisfaction pink esthetic score and patient satisfaction

时间窗: at delivery time

by questionnaire

次要结局

未报告次要终点

研究者

发起方
Kholoud Mohamed Mahmoud Soliman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kholoud Mohamed Mahmoud Soliman

Specialist prosthodontist

Al-Azhar University

研究点 (1)

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