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临床试验/NCT05990283
NCT05990283已完成不适用

Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Modified bleeding index

研究概览

简要总结

Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Before implant surgery, patients were randomized into socket shield technique and guided bone regeneration groups. While the buccal gap was untreated in the socket shield group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal thickness were recorded at the permanent restoration and the postoperative first year. Horizontal bone level and vertical bone level were assessed with cone beam computed tomography images taken before the surgery and one year after prosthesis insertion. The pink esthetic score was evaluated with intraoral photographs taken before the surgical procedure and first-year follow-up.

详细描述

This study aimed to compare the non-grafted socket shield technique with simultaneously guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and radiographic parameters. Within the scope, immediate implant placement was applied to randomized groups (socket shield technique and guided bone regeneration). Immediate implant placement was performed following shield preparation in the shield group, and guided bone regeneration was applied in the regeneration group. A temporary non-functional immediate prosthesis was inserted at the same visit. After four months, permanent restorations were applied. Clinical, radiographic, and esthetic parameters were compared between two groups at baseline and first-year follow-up.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with the health status of American Society of Anesthesiologists class I or II,
  • Nonsmokers,
  • Unrestorable single-rooted tooth in the maxillary esthetic region,
  • Periodontally healthy, non-mobile teeth,
  • Single implant placement,
  • Minimum 3-5 mm available vertical bone apical to the apex,
  • Intact socket wall after extraction.

排除标准

  • Medically compromised patients, especially uncontrolled diabetes,
  • Psychiatric problems,
  • Pregnancy, lactation, or suspicion of pregnancy,
  • A history of radiation therapy to the head and neck region or immunosuppressive therapy,
  • Metabolic bone disorder or the presence of drugs known to affect bone metabolism,
  • Poor plaque control,
  • Vertical root fracture on the buccal surface or a horizontal fracture below the bone level,
  • External or internal resorption affecting the buccal part of the root,
  • Acute infection in the area intended for implant placement,
  • Refusal to attend follow-up appointments.

结局指标

主要结局

Modified bleeding index

时间窗: Four months after implant restoration and first-year follow-up

An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome

Radiographic bone level in the vertical dimension

时间窗: Before implant surgery and first year follow-up

Vertical bone level measured at cone beam computed tomography images

Keratinized mucosa width

时间窗: Four months after implant restoration and first-year follow-up

The distance from the peri-implant mucosa margin to the mucogingival junction

Peri-implant probing depth

时间窗: Four months after implant restoration and first-year follow-up

Probing depth measured by Williams periodontal probe

Radiographic bone level in the horizontal dimension

时间窗: Before implant surgery and first year follow-up

Horizontal bone level measured at cone beam computed tomography images

Modified plaque index

时间窗: Four months after implant restoration and first-year follow-up

An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome

Mucosal thickness

时间窗: Four months after implant restoration and first-year follow-up

The thickness measured at 1.5 mm from the margin by the endodontic spreader

Pink esthetic score

时间窗: Before implant surgery and first year follow-up

A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi Gürbüz

Assistant Professor

Kutahya Health Sciences University

研究点 (2)

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