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临床试验/CTRI/2024/05/067064
CTRI/2024/05/067064尚未招募4 期

Socket Shield Technique versus Conventional Delayed Implant Placement with Immediate Temporisation in Maxillary Premolar Region for evaluation of Clinical Outcomes: A Quasi-Experimental Study

Self1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
Self
入组人数
44
试验地点
1
主要终点
1 bone loss between implant

研究概览

简要总结

Aim: The present study aimed to compare the socket shield technique with immediate temporization vs the conventional delayed implant placement with immediate temporization in the maxillary premolar region. The primary outcome is the assessment of the horizontal and vertical dimensional changes of the labial plate of bone, implant stability, pink esthetic score (PES) evaluation, and patient satisfaction.

Research Question: Is there a difference in the amount of bone loss, implant stability, pink esthetic score and patient satisfaction between implants placed using the socket shield technique with immediate temporisation and conventional delayed implant placement with immediate temporisation in the maxillary premolar region?

Primary Hypothesis: There is no difference in the amount of bone loss, implant stability, pink esthetic score and patient satisfaction between implant placed using the socket shield technique with immediate temporisation and conventional delayed implant placement with immediate temporisation in the maxillary premolar region.

Alternate Hypothesis: There is a difference in the amount of bone loss, implant stability, pink esthetic score and patient satisfaction between implants placed using the socket shield technique with immediate temporisation and conventional delayed implant placement with immediate temporisation in the maxillary premolar region.

Clinical Significance: It will help the clinician to decide whether the remaining natural root can be preserved; to prevent the natural process of bone resorption; and will give a choice of Immediate implant placement and prosthetic rehabilitation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria:
  • Patients who are willing to participate in the study.
  • Patients of both the genders with age range of 20 to 65 years.
  • Nonrestorable maxillary premolar teeth.
  • Patient with healed edentulous maxillary premolar region
  • Fairly intact buccal periodontal tissues.
  • Any periodontal phenotype (thick or thin).
  • Patient with good oral hygiene.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

排除标准

  • Exclusion criteria:
  • Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus
  • Patient with history of radiation therapy to the head and neck region.
  • Heavy smoker patients.
  • Teeth with periodontal disease.
  • Vertical root fracture
  • Horizontal fracture at or below the bone level 7.

结局指标

主要结局

1 bone loss between implant

时间窗: Baseline, 3 months, 6 months, 1 year

2 implant stability

时间窗: Baseline, 3 months, 6 months, 1 year

3 pink esthetic score

时间窗: Baseline, 3 months, 6 months, 1 year

4 patient satisfaction

时间窗: Baseline, 3 months, 6 months, 1 year

次要结局

未报告次要终点

研究者

发起方
Self
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shruti Potdukhe

MGM Dental college and hospital, Navi Mumbai

研究点 (1)

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