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Cover Screw vs Healing Abutment on Osseointegration

2026年6月30日 更新者：Zeliha Başak Çakır Erdil

EFFECTS OF COVER SCREW AND HEALING ABUTMENT ON EARLY IMPLANT STABILITY: A RANDOMIZED CONTROLLED CLINICAL TRIAL

This randomized split-mouth clinical trial aims to compare the effects of using a cover screw versus a healing abutment on early implant stability and osseointegration. Patients requiring at least two dental implants will receive both interventions in a split-mouth design, with one implant randomly assigned to the cover screw group and the contralateral implant assigned to the healing abutment group. Implant stability will be assessed using resonance frequency analysis (RFA) and Implant Stability Quotient (ISQ) measurements during the healing period.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This prospective randomized split-mouth controlled clinical trial evaluates the effects of cover screw placement and healing abutment placement on early implant stability and osseointegration. Systemically healthy patients requiring at least two dental implants will be enrolled. Using a split-mouth design, each participant will receive both interventions, with one implant randomly allocated to receive a cover screw (two-stage protocol) and the contralateral implant to receive a healing abutment (one-stage protocol).

Implant stability will be evaluated by insertion torque and resonance frequency analysis (RFA). Implant Stability Quotient (ISQ) values will be recorded at implant placement and at the 3-month follow-up. The primary objective is to compare changes in implant stability (ΔISQ) between the two treatment protocols. Secondary outcomes include implant survival, peri-implant soft tissue healing, and postoperative complications.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Merkez
      • Adıyaman、Merkez、土耳其（türkiye）、02030
        • Faculty of Dentistry, Adıyaman University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged ≥18 years. American Society of Anesthesiologists (ASA) physical status I or II. Able and willing to comply with the study protocol and follow-up schedule. Required at least two dental implants in contralateral or symmetrical edentulous sites.

Implant sites free of active infection or acute periodontal disease. Adequate oral hygiene. Sufficient bone volume for placement of a standard-diameter implant with at least 1.5 mm of surrounding peri-implant bone.

Keratinized mucosal width ≥2 mm. Soft tissue thickness ≥2 mm. Written informed consent provided.

Exclusion Criteria:

  • Systemic diseases or medical conditions contraindicating implant surgery. Uncontrolled diabetes mellitus (HbA1c >10%). Current intravenous antiresorptive therapy. History of head and neck radiotherapy. Immunosuppressive therapy. Active malignancy. Uncontrolled hypertension. Advanced hepatic or renal insufficiency. Pregnancy. Poor oral hygiene. Active oral infection. Requirement for bone augmentation before implant placement. Inadequate bone volume. Unfavorable peri-implant soft tissue phenotype. Primary implant stability <20 Ncm at implant placement.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Healing Abutment
Dental implants were restored with a healing abutment at the time of implant placement using a one-stage surgical protocol. Implant stability and osseointegration were evaluated during the follow-up period.
设备：Healing Abutment
A healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol.
有源比较器：Cover Screw
Dental implants were restored with a cover screw at the time of implant placement using a conventional two-stage surgical protocol. Implant stability and osseointegration were evaluated during the follow-up period.
设备：Cover Screw
A cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Implant Stability Quotient (ISQ)
大体时间：Baseline (implant placement) to 3 months after implant placement
Implant stability was assessed using resonance frequency analysis (RFA). Changes in Implant Stability Quotient (ISQ) values from implant placement to the 3-month follow-up were compared between the healing abutment and cover screw groups.
Baseline (implant placement) to 3 months after implant placement

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Zeliha Başak Çakır Erdil

调查人员

  • 研究主任：METİN çalışır, Prof.Dr.、Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月26日

初级完成 (实际的)

2026年3月24日

研究完成 (实际的)

2026年3月24日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HRU-25.04.15

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because of institutional policies and the need to protect participant confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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