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临床试验/NCT07589140
NCT07589140尚未招募不适用

Influence of Alveolar Bone Drilling and Anatomical Position on the Primary Stability, Osseointegration and Functioning of Immediately Placed Dental Implants

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
试验地点
1
主要终点
Implant success

研究概览

简要总结

The goal of this clinical trial is to learn if alveolar bone drilling and anatomical position of an immediately placed dental implant has influence on the primary stability, osseointegration and function. It aims to answer these questions:

  • Does absence of alveolar drilling before implant placement give the same result as traditional osteotomy with apical drilling?
  • Is palatinal root position of implant as succesful as central position?

Researchers will compare crestal bone levels and primary stability of the implant after insertion in the groups. Subjects will be assigned to groups, acoording to clinical situation. Study groups:

  1. Dental implants will be placed in the extraction socket with an apical osteotomy.
  2. Dental implants will be placed in the extraction socket without performing an osteotomy.
  3. Dental implants will be placed in the centre of the extracted maxillary molar socket.
  4. Dental implants will be placed into the palatal root socket of the extracted maxillary molar.

详细描述

Tooth extraction and subsequent implantation will be performed under local anesthesia. After tooth extraction, an osteotomy is performed in the tooth socket to create a bed for the implant. The patients will be divided into groups based on the bone condition after tooth extraction. Participants in this study were scheduled for tooth extraction followed by immediate implant placement. One hour prior to the procedure, patients were administered 1 g of amoxicillin orally, which was continued at a dosage of twice daily for one week after the procedure. Teeth were extracted under local anesthesia using 4% articain with epi-nephrine 1:100000 (Ubistesin forte, 3M ESPE, USA), with an emphasis on minimizing trauma and avoiding flap elevation, employing root sectioning if necessary. Care was taken to preserve the marginal gingiva and papillae. Following extraction, the socket was cleaned and assessed. Osteotomies were created using the original drills in a sequence specified by the implant manufacturer. The implant was placed centrally in the me-sio-distal aspect and more towards the lingual/palatal side of the socket. The insertion torque was recorded with manual torque wrench. Anatomical or individual healing abutments were used after implant placement. Individual healing abutments were crafted chairside using original titanium temporary abutments and flowable composite, creating critical and subcritical contours. The composite was polished meticulously. All healing abutments were secured on the implants with 15 Ncm torque. Postoperative instructions were provided both verbally and, in a booklet, advising patients to rinse their mouths twice daily for 2 weeks with a commercially available mouth rinse containing 0.12% chlorhexidine di-gluconate.

After 4 months, the osseointegration of implants was evaluated for presence or absence of following symptoms: pain, recurrent peri-implant infections, mobility on manual palpation and continuous peri-implant radiolucency. If those symptoms were absent, implant was deemed successfully integrated and implant schedulled for restoration. During prosthetic visit, open tray transfer was connected to the implant and open tray silicone impressions for final restorations were taken. Healing abutment put back to the implant. In the lab a screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the polishing protocol were fabricated. At the delivery date, zirconia crown retained to the implant with fingers and torqued to 35N/cm using implant wrentch. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite . Individual oral hygiene instructions were provided both verbally and in booklet form. Scheduling of follow-up visits were carried out after 1 year of last dental visit.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • ≥ 18 years old.
  • healthy patients without medical contraindications for dental implantation surgery.
  • removable and non-molar teeth indicated for extraction in both jaws
  • healthy soft tissues (bleeding on probing < 20%, plaque index < 25%);
  • intact alveolar bone walls post-extraction
  • signed informed consent form and permission to use the obtained data for research purposes.

排除标准

  • Smokers (≥ 10 cigarettes per day);
  • history of uncontrolled periodontitis;
  • uncontrolled diabetes/alcoholism;
  • use of drugs that may affect healing;
  • persons who, due to health status, cannot be considered capable of reasonably assessing their interests;

研究组 & 干预措施

Apical osteotomy

Experimental

Megagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction

干预措施: dental implant placement (Procedure)

Center molar

Experimental

Megagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket.

干预措施: Dental implant (Device)

Palatinal molar

Experimental

Megagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar.

干预措施: dental implant placement (Procedure)

Center molar

Experimental

Megagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket.

干预措施: dental implant placement (Procedure)

Apical osteotomy

Experimental

Megagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction

干预措施: Dental implant (Device)

Mesiodistal stability

Experimental

Megagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy.

干预措施: dental implant placement (Procedure)

Mesiodistal stability

Experimental

Megagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy.

干预措施: Dental implant (Device)

Palatinal molar

Experimental

Megagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar.

干预措施: Dental implant (Device)

结局指标

主要结局

Implant success

时间窗: 16 weeks after implant placement

Implant will be considered integrated if implant will meet criteria follwing criteria: •. The implant is in its original position. * There are no persistent complaints. * There is no peri-implant inflammation. * There is no implant loosening. * There is no peri-implant radiolucency.

次要结局

  • Marginal bone stability after one year post-treatment(1 year after delivery of final crown on an implant)
  • Implant insertion primary stability(At "Day 1" of implant placement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomas Linkevicius

Principal investigator

Lithuanian University of Health Sciences

研究点 (1)

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