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Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla

2026年5月1日 更新者:Aleksa Markovic、University of Belgrade

Immediate Vs Early Loading Protocols in Rehabilitation of Healed Fully Edentulous Maxilla

The goal of this clinical trial is to compare immediate versus early loading protocols for complete implant-supported fixed dental prostheses in healed edentulous maxillae.

The main questions it aims to answer are:

  • How does the timing of delivery of the prosthesis affect the stability of the implant and the surrounding soft and bone tissue?
  • Does prosthesis delivery time affect quality of life and patient satisfaction? Researchers will compare immediate and early (6 weeks after implant placement) loading protocols in rehabilitation of fully edentulous upper jaw.

Participants will:

  • Receive 6 dental implants in the edentulous upper jaw and after that complete fixed dental prostheses will be delivered immediately or 6 weeks after implant placement.
  • Visit the clinic at the scheduled time for checkups and tests

研究概览

详细说明

Surgical protocol Prior to surgery antibiotic prophylaxis (2 g amoxicillin with clavulonic acid or, in case of allergy, 0.6 g clindamycin, 1 hour before the procedure) and antiedema therapy (0.004 g dexamethasone 1 hour before the procedure) was administered. Patients rinsed their mouth using 15 mL of 0.12% chlorhexidine solution for 1 minute preoperatively. The surgical procedures were performed under local anesthesia using 4% articaine, 1:100.000 epinephrine. Centers of the intended implant sites were marked according to the reference marks present in the patient's existing complete removable denture that had been used as the radiographic stent. A midcrestal incision was made, then full-thickness buccal and palatal flaps were elevated. Implant sites were prepared by strictly adhering to the manufacturer's protocol for low-density bone using drills of increasing diameter (Institut Straumann). To provide adequate primary implant stability, underpreparation was performed: 1. In low-density type D3 bone, the profile drill was skipped; and 2. In low-density type D4 bone, the final sequence and profile drills were skipped. Intermittent drilling under copious irrigation was performed with low hand pressure and a physiodispenser running between 600 and 800 rpm. A total of 144 sites were prepared, followed by placement of 144 SLActive surface (Bone Level Tapered, Institut Straumann) implants. Bone quality was assessed according to the Lekholm and Zarb classification. In sites with dehiscence or fenestration resulting in an exposed implant surface, localized bone augmentation was performed using bovine-derived xenograft (Geistlich Bio-Oss, Geistlich, Wolhusen, Switzerland) and covered with a type 1 collagen membrane (Geistlich Bio-Gide, Geistlich). Healing screws (Institut Straumann; NC healing abutment Ø4.8 mm conical 5 mm and RC healing abutment Ø5 mm conical 6 mm) were placed and primary wound closure was achieved with 5-0 single resorbable sutures (AssuCryl Lactin, Assut Sutures of Switzerland, Pully-Lausanne, Switzerland). Patients were discharged with recommendations regarding dietetic and hygienic regimens. Antibiotic protocol consisted of 2 g amoxicillin with clavulonic acid (divided into 2 doses) or, in case of allergy, 1.8 g clindamycin daily (divided into 3 doses) for the following 5 days. Antiedema therapy (0.004 g dexamethasone) was administered 24 hours postoperatively. Prosthetic protocol After dental implant placement, patients were randomly assigned to immediate loading or early loading groups.

Implants for patients from Test Group were immediately loaded using S-R abutments (Institut Straumann) with temporary restorations. Patients from Control Group did not receive any kind of prosthetic temporization and were left with healing abutments. For Test Group an open-tray impression technique was used for provisional restoration. Impressions were made using: ASilicone material (Hydrorise implant, Zhermack, Badia Polesine, Italy), splinted impression posts (RC and NC impression post, Straumann) and a plastic impression tray (Miratray, Hager Werken, Duisburg, Germany). Provisional restorations were made digitally with polymethyl methacrylate (PMMA) (Telio CAD, Ivoclar Vivadent, Schaan, Lichtenstein). Plaster models with scan bodies were digitized with a laboratory scanner (3Shape E1, 3Shape, Copenhagen, Denmark). Final virtual design of provisional restoration was performed with 3D design software (exocad Matera 2.3, Exocad, Darmstadt, Germany). Drilling of PMMA blocks was performed in a 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). The following final Straumann screw retained abutments for the prosthetic bridge (Institut Straumann) were chosen according to implant angulation and surrounding soft tissue height. For the interface between the screw-retained abutments and final prosthetic work, copings for screw retained abutments (Institut Straumann) were used and bonded to the final prosthesis.

At the end of the 6-week healing period for both groups, definitive prosthetic restorations were delivered. In preparation for the definitive prosthesis, a final open-tray impression was taken with an individual tray and polyether material (Impregum Soft, 3M Espe, Seefeld, Germany). An analog ceramic layering technique was performed in the process of producing a porcelain fused to metal restoration (Shofu Vintage Halo Porcelain, Shofu Dental Corporation, Ratingen, Germany). The metal framework was made using cobalt chromium metal powder material (Starbond Easy Powder 45, Scheftner, Mainz, Germany) with additive manufacturing technologies (EOS, Krailling, Germany).

研究类型

介入性

注册 (实际的)

24

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

      • Belgrade、塞尔维亚、11000
        • Implant Center, School of Dental Medicine, University of Belgrade

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

是的

描述

Inclusion Criteria:

  1. Patients in good general health with no current history of systemic disease or medication use that could interfere with the treatment;
  2. Patients with complete maxillary edentulism who had lost their teeth at least 6 to 8 weeks prior to the proposed ''allon- six'' implant rehabilitation; and
  3. Clinically compliant patients consenting to be enrolled into the study.

Exclusion Criteria:

  1. Active or chronic disease that affects bone metabolism or wound healing;
  2. Diminished mental capacities that could mitigate the ability to comply with the protocol;
  3. Residual roots or teeth;
  4. History of maxillary augmentation;
  5. Oral carcinoma or inflammatory changes; and
  6. History of head and neck radiotherapy.

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Immediately loading
Implants will be loaded with temporary prosthesis immediatelly after their insertion
Implants will be immediately loaded using S-R abutments (Institut Straumann) with temporary restorations. An open-tray impression technique was used for provisional restoration. Provisional restorations were made digitally with polymethyl methacrylate (PMMA) (Telio CAD, Ivoclar Vivadent, Schaan, Lichtenstein). Plaster models with scan bodies were digitized with a laboratory scanner (3Shape E1, 3Shape, Copenhagen, Denmark). Final virtual design of provisional restoration was performed with 3D design software (exocad Matera 2.3, Exocad, Darmstadt, Germany). Drilling of PMMA blocks was performed in a 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). After 6 weeks they will receive final prosthesis.
其他名称:
  • 测试组
有源比较器:Early loading
Implants will be left to heal with healing abutments for 6 weeks without prosthesis
At the end of the 6-week healing period, definitive prosthetic restorations were delivered. In preparation for the definitive prosthesis, a final open-tray impression was taken with an individual tray and polyether material (Impregum Soft, 3M Espe, Seefeld, Germany). An analog ceramic layering technique was performed in the process of producing a porcelain fused to metal restoration (Shofu Vintage Halo Porcelain, Shofu Dental Corporation, Ratingen, Germany). The metal framework was made using cobalt chromium metal powder material (Starbond Easy Powder 45, Scheftner, Mainz, Germany) with additive manufacturing technologies (EOS, Krailling, Germany).
其他名称:
  • 控制组

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
Implant stability
大体时间:Implant stability will be measured at the time of implant placement (baseline) and at post-op week 6 (prior to delivery of definitive prosthetic restoration) and then after 5, 10 and 15 years
Implant stability will be recorded by Osstell Mentor and Penguin using Resonance frequency analysis (RFA) method. Results were recorded on an implant stability scale (ISQ) from 1 to 100. The higher the ISQ, the more stable the implant was.21 Two consecutive measurements delivering the same ISQ values were considered authentic.
Implant stability will be measured at the time of implant placement (baseline) and at post-op week 6 (prior to delivery of definitive prosthetic restoration) and then after 5, 10 and 15 years

次要结果测量

结果测量
措施说明
大体时间
Insertion torque
大体时间:During surgery, at implant placement in prepared implant site.
Insertion torque was measured with a torque wrench (Institut Straumann) and recorded in Ncm.
During surgery, at implant placement in prepared implant site.
Marginal bone loss change from baseline to 5,10 and 15 years follow up
大体时间:At final prosthesis delivery (baseline), after 5,10 and 15 years follow up
Following prosthesis and multiunit abutment removal, standardized healing abutments (identical to baseline protocol) were placed. CBCT images were acquired at the same exposure parameters as baseline and analyzed by one blinded examiner using OnDemand3D software (Cybermed Inc., Seoul, South Korea). MBL was measured as the linear distance from the implant shoulder to first bone-implant contact at four sites per implant: mesial, distal, buccal, and palatal aspects.
At final prosthesis delivery (baseline), after 5,10 and 15 years follow up
Changes in Buccal Plate thickness from baseline to 5,10 and 15 years follow up
大体时间:At final prosthesis delivery (baseline) to 5,10 and 15 years follow up
Following prosthesis and multiunit abutment removal, standardized healing abutments (identical to baseline protocol) were placed. CBCT images were acquired at the same exposure parameters as baseline and analyzed by one blinded examiner using OnDemand3D software (Cybermed Inc., Seoul, South Korea). BPT was measured perpendicular to the implant axis at two locations: 2 mm apical to the implant-abutment connection and at implant midlength.
At final prosthesis delivery (baseline) to 5,10 and 15 years follow up
Oral health-related quality of life
大体时间:At implant placement (baseline), 1 month after definitive prosthesis delivery, and after 5,10 and 15 years
Oral health-related quality of life was evaluated using the OHIP-19 questionnaire. It consists of 19 questions and patients rated each item on a 5-point scale, where 0 indicated "never" and 4 indicated "constantly." The total OHIP-19 score was obtained by summing the scores from all questions. Lower score meant improved quality of life.
At implant placement (baseline), 1 month after definitive prosthesis delivery, and after 5,10 and 15 years
Patient satisfaction
大体时间:At implant placement (baseline), 1 month after final prosthesis delivery and after 5,10 and 15 years follow up.
Patients specified their level of satisfaction related to function, esthetics, and discomfort/pain by indicating a position along a 10-cm line between 2 endpoints where the beginning of the line was marked as complete unsatisfaction and the end as maximum satisfaction on Visual Analogue Scale.
At implant placement (baseline), 1 month after final prosthesis delivery and after 5,10 and 15 years follow up.
Implant survival rate
大体时间:1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Implant survival was defined as implant in situ regardless of condition or peri-implant disease presence.
1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Prosthesis survival rate
大体时间:1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Prosthesis survival was defined as original prosthesis in function with or without minor repairs.
1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Complications
大体时间:1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Biological complications (implant failure requiring removal, peri-implantitis, peri-implant mucositis) and mechanical complications (prosthesis fracture, veneer chipping, screw loosening/fracture, abutment complications) were recorded.
1 month after final prosthesis delivery, after 5, 10 and 15 years follow up

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2019年3月1日

初级完成 (估计的)

2035年3月1日

研究完成 (估计的)

2035年3月1日

研究注册日期

首次提交

2026年5月1日

首先提交符合 QC 标准的

2026年5月1日

首次发布 (实际的)

2026年5月7日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年5月1日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

1 month, 5 years, 10 years and 15 years outcomes will be published in the journal.

IPD 共享时间框架

2022-2036

IPD 共享访问标准

The investigators will share analyzed outcomes, surgical and prosthetic protocols.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

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

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