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Immediate Implant Placement With Subepithelial Connective Tissue Grafting and Probiotics

2026年5月13日 更新者:Walid Elamrousy、Kafrelsheikh University

Comparative Evaluation of Platelet-Rich Fibrin Versus Probiotics as Adjuncts to Immediate Implant Placement Combined With Subepithelial Connective Tissue Grafting: Clinical, Biological, and Radiographic Peri-Implant Tissue Outcomes A Parallel-Arm Randomized Trial

The present study aims to evaluate and compare the clinical, radiographic, and biological peri-implant tissue outcomes of platelet-rich fibrin versus probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting in adults requiring single immediate implant placement.

研究概览

详细说明

Dental implant therapy in the esthetic zone is currently judged not only by implant survival but also by preservation of peri-implant hard and soft tissues, maintenance of facial mucosal stability, and achievement of acceptable esthetic outcomes. Immediate implant placement is attractive because it may shorten treatment time, reduce the number of surgical procedures, and preserve the restorative pathway. Nevertheless, immediate placement does not eliminate the physiologic remodeling that follows tooth extraction, particularly at the facial aspect of the socket. Recent evidence has shown that even when immediate implants are successfully integrated, post-extraction dimensional changes may still compromise mucosal contour, midfacial level, and long-term esthetic integration.

Because implant timing alone cannot fully prevent hard- and soft-tissue alteration, contemporary immediate implant therapy increasingly incorporates peri-implant tissue augmentation procedures. Among these, peri-implant soft-tissue augmentation has become an important component of treatment planning because it may improve tissue volume, phenotype, and esthetic stability. Current evidence also indicates that autogenous grafts generally provide more favorable peri-implant soft-tissue augmentation outcomes than substitute materials. In parallel, adequate keratinized mucosa continues to be associated with better peri-implant clinical conditions and lower risk of peri-implant disease, highlighting the importance of peri-implant soft-tissue quality as both an esthetic and biologic determinant of treatment success. Additional systematic evidence has further supported the positive relationship between keratinized mucosa and peri-implant health and stability.

Within this context, subepithelial connective tissue grafting has become a key strategy for enhancing peri-implant mucosal thickness and supporting facial mucosal stability around immediate implants. Randomized clinical evidence has shown that connective tissue grafting performed with single immediate implants in the maxillary esthetic zone can improve mid-buccal mucosal stability over long-term follow-up. Other randomized data have also demonstrated favorable esthetic and peri-implant tissue outcomes when soft-tissue grafting is incorporated into immediate implant protocols. More recent volumetric clinical findings have reinforced the importance of peri-implant soft-tissue volume in limiting unfavorable midfacial mucosal alterations after immediate implant placement.

Although subepithelial connective tissue grafting is an established soft-tissue approach, interest has grown in adjunctive biologic interventions that may further enhance wound healing and peri-implant tissue maturation. Platelet-rich fibrin has received considerable attention because it is an autologous fibrin matrix rich in platelets, leukocytes, and growth factors that may promote angiogenesis, fibroblast proliferation, soft-tissue healing, and early tissue remodeling. Recent clinical evidence has shown that leukocyte-platelet-rich fibrin may improve peri-implant mucosal dimensions and soft-tissue enhancement around implants. In addition, systematic review and meta-analytic evidence suggest that injectable platelet-rich fibrin can positively influence gingival phenotype modification, supporting its biologic plausibility as an adjunctive soft-tissue enhancer.

At the same time, probiotics have emerged as a potentially valuable adjunct in implant dentistry because of their capacity to regulate the oral microbiome, modulate inflammatory pathways, and influence host immune balance. Recent evidence has suggested that probiotics may promote bone homeostasis, facilitate tissue regeneration, and reduce peri-implant inflammatory burden through control of dysbiosis and host modulation. Systematic review evidence in peri-implant oral diseases has shown that probiotic therapy may improve certain clinical and inflammatory parameters, although the available data remain heterogeneous and not yet definitive. More recent meta-analytic findings have similarly indicated that probiotics may provide adjunctive benefits in peri-implant disease management, while also confirming the need for further well-designed trials.

Beyond clinical and esthetic evaluation, biologic monitoring has become increasingly important in peri-implant research. Peri-implant crevicular fluid biomarkers may provide insight into inflammatory activity and tissue remodeling before overt clinical breakdown becomes evident. Among these biomarkers, matrix metalloproteinase-8 has attracted particular attention because it is closely associated with collagen degradation and peri-implant inflammatory activity, making it one of the most relevant biologic markers for assessing peri-implant tissue breakdown.

Despite the expanding literature on immediate implant placement, peri-implant soft-tissue grafting, platelet-rich fibrin, probiotics, and biomarker-based peri-implant assessment, there is still no clear randomized clinical evidence directly comparing platelet-rich fibrin and probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting. Therefore, the rationale of the present study is to evaluate whether these two biologically distinct adjunctive approaches differ in their clinical, radiographic, and biologic effects on peri-implant tissue outcomes, thereby helping to optimize peri-implant tissue management in immediate implant therapy.

研究类型

介入性

注册 (估计的)

22

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。

学习联系方式

研究联系人备份

学习地点

    • Kafrelsheikh
      • Kafr ash Shaykh、Kafrelsheikh、埃及、214312
        • Faculty of Dentistry, Kafrelsheikh 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

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Adults aged 20 to 45 years.
  • Systemically healthy patients eligible for implant surgery.
  • Patients requiring extraction of a single non-restorable tooth indicated for immediate implant placement.
  • Implant sites located in the maxillary esthetic or para-esthetic zone.
  • Sites with sufficient apical and/or palatal bone to permit correct three-dimensional implant positioning and achieve adequate primary stability.
  • Sites suitable for simultaneous subepithelial connective tissue grafting.
  • Patients with acceptable oral hygiene and good compliance with periodontal and implant treatment.
  • Patients willing to attend all follow-up visits and comply with study instructions.

Exclusion Criteria:

  • Medically compromised patients or patients with systemic conditions that may contraindicate implant surgery or interfere with healing.
  • Smokers.
  • Pregnant or lactating women.
  • Patients with uncontrolled periodontal disease or poor oral hygiene.
  • Patients with acute infection at the intended implant site.
  • Patients with insufficient bone volume preventing immediate implant placement with adequate primary stability.
  • Patients with a history of head and neck radiotherapy or chemotherapy.
  • Patients receiving bisphosphonates or other medications known to affect bone metabolism or soft tissue healing.
  • Patients with parafunctional habits that may jeopardize implant stability or restorative success.
  • Patients unwilling or unable to complete the follow-up period.

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:platelet-rich fibrin group
Immediate implant placement with subepithelial connective tissue grafting and adjunctive platelet-rich fibrin
platelet-rich fibrin will be prepared immediately before application using freshly drawn autologous venous blood and a standardized centrifugation protocol selected according to the equipment available in the study setting. The prepared PRF will be used as an adjunct to the immediate implant and subepithelial connective tissue grafting procedure according to the finalized protocol, either locally around the peri-implant site and/or in intimate relation to the grafted soft tissue to enhance healing and tissue maturation.
实验性的:probiotics group
Immediate implant placement with subepithelial connective tissue grafting and adjunctive probiotics
Probiotics probiotics will be administered as an adjunct to the immediate implant and subepithelial connective tissue grafting The mode of delivery, dose, and duration will be standardized for all patients allocated to this group.

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
evaluation of matrix metalloproteinase-8 (MMP-8) levels
大体时间:12-months

Biological assessment will be performed by collecting peri-implant sulcular fluid samples for evaluation of matrix metalloproteinase-8 (MMP-8) levels.

After gentle removal of supragingival plaque, the peri-implant site will be isolated with cotton rolls and dried with mild air flow. Sterile PerioPaper strips will be inserted carefully into the peri-implant sulcus until slight resistance is encountered and left in place for 30 seconds. Any strip contaminated with blood or saliva will be discarded. The collected samples will be transferred to sterile Eppendorf tubes and stored until analysis.

Quantitative assessment of MMP-8 will be carried out using a human MMP-8 ELISA kit according to the manufacturer's protocol.

12-months

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。

调查人员

  • 首席研究员:walid elamrousy, phd、Kafrelsheikh University

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 (估计的)

2026年5月14日

初级完成 (估计的)

2027年5月20日

研究完成 (估计的)

2027年5月30日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • KFSIRB200-1008

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

upon request

IPD 共享时间框架

12 months

IPD 共享支持信息类型

  • 研究方案

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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