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临床试验/NCT07433920
NCT07433920招募中不适用

L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted/Computer-Guided Socket Shield Immediate Dental Implantation: A Randomized Clinical Trial

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年2月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
marginal bone level

研究概览

简要总结

the rationale of the current study is to address a focused and clinically relevant gap in socket shield therapy: which biologic modality best supports healing of the shield-implant gap when SST is performed under a standardized, digitally guided workflow. The study will compare three shield-implant gap filling modalities: (i) L-PRF alone (without membrane), (ii) sticky tooth (autogenous dentin graft +i- PRF), and (iii) sticky bone (particulate graft + i- PRF) under AI-assisted, patient-specific guided implant placement based on IOS/CBCT superimposition, with CBCT follow-up at immediate, 3 months, and 6 months. The working hypothesis is that biologically active, cohesive composites (sticky tooth and sticky bone) will provide superior hard- and soft-tissue dimensional stability compared with PRF alone by improving space maintenance and early wound stability in the shield-implant gap . The null hypothesis is that there will be no statistically significant differences between the three modalities in radiographic and digitally assessed clinical outcomes over the 6-month follow-up period .

详细描述

The socket shield technique (SST), a form of partial extraction therapy, was introduced to address the facial-bundle-bone problem by intentionally retaining a buccal root fragment with its periodontal ligament to help maintain blood supply and support the facial plate.

Among biologic options for filling peri-implant gaps, platelet-rich fibrin (PRF) is attractive because it is autologous, inexpensive, and provides a fibrin scaffold with a sustained release of growth factors that may support angiogenesis and early tissue maturation. At the cellular and molecular level, De Bruyn et al. (2024) demonstrated that leukocyte- and platelet-rich fibrin contains a complex cellular ecosystem and growth factor kinetics that can plausibly support regenerative wound healing, strengthening the biologic rationale for using L-PRF in challenging healing environment. A recent systematic review in Minerva Dental and Oral Science (2024/2025) also concluded that PRF may aid peri implant gap fill and soft-tissue healing in immediate implant contexts, but called for better standardized trials and clearer indications.

Beyond PRF alone, two "composite" concepts have gained attention: sticky tooth and sticky bone. Sticky tooth generally refers to autogenous tooth-derived dentin granules combined with platelet concentrates to create a cohesive graft, leveraging dentin's mineral and collagen composition and its proposed bioactivity. In a histologic evaluation, van Orten et al. (2022) described tooth-derived granules mixed with PRF ("sticky tooth") as a feasible socket preservation approach with histologic evidence of graft integration patterns consistent with bone remodeling, supporting its potential as an autogenous biomaterial with low immunologic risk. Separately, tooth-derived grafts have been increasingly investigated as alternatives to xenografts/allografts, yet protocols vary widely in processing, particle size, sterilization, and mixing with blood products-creating a knowledge gap regarding standardization and reproducibility across centers.

Sticky bone most commonly refers to particulate bone substitute (often xenograft or allograft) combined with injectable PRF (i-PRF) to form a moldable, fibrin-rich mass intended to improve handling, stabilize particles, and potentially enhance early biologic activity. In a randomized parallel-arm clinical trial, Tony et al. (2022) assessed sticky bone for horizontal ridge augmentation using CBCT outcomes, supporting that i-PRF-based composites can be evaluated quantitatively and may influence hard-tissue results depending on adjunctive membrane use.

Collectively, these findings suggest a strong rationale to test whether sticky tooth and sticky bone can serve as optimized fillers for the shield-implant gap in SST-where space maintenance, clot stability, and early vascularization may be decisive.

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
Single (Outcomes Assessor)

盲法说明

outcome assessor is masked

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically healthy patients according to the American Society of Anesthesiologists (ASA) physical status classification system; only patients belonging to ASA I and ASA II categories will be included in this study.
  • Age > 18 years.
  • Patients presenting with one non-restorable hopeless anterior tooth due to extensive caries, cervical/root fracture, vertical or oblique root fracture, multiple failed endodontic treatments, or root resorption.
  • Sufficient apical/palatal bone to obtain primary implant stability.

排除标准

  • Patients belonging to ASA III, ASA IV and ASA V will be excluded.
  • Vertical root fracture involving the labial aspect of the root planned to be retained as the facial shield.
  • Horizontal root fracture that is too far apically located.
  • Presence of acute (active) periapical infection.
  • Large chronic periapical lesion.
  • Lack of sufficient bone apical to the extraction socket to obtain primary stability. * Ankylosed tooth positioned too apically in relation to adjacent teeth.

研究组 & 干预措施

PRF alone group

Active Comparator

Immediately after implant placement, leukocyte-platelet rich fibrin (L-PRF) will be prepared, then gently packed into the implant-shield gap

干预措施: Socket shield with PRF (Procedure)

Sticky tooth group

Experimental

The extracted palatal root portion will be cleaned and processed chairside into dentin particles, then mixed with PRF clot to form "sticky tooth" that will be packed into the implant-shield gap

干预措施: Sticky tooth group (Procedure)

Sticky bone group

Experimental

xenograft will be mixed with PRF clot to form "sticky bone" that will be packed into the implant-shield gap

干预措施: Sticky bonegroup (Procedure)

结局指标

主要结局

marginal bone level

时间窗: 12 months

marginal bone level (FMBL) will be recorded as the vertical distance (mm) from the implant shoulder (or implant platform reference) to the most coronal point of the facial bone crest on the midfacial aspect

次要结局

  • Peri-implant vertical bone defect depth(12 months)

研究者

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

Walid Elamrousy

Professor of periodontology, Faculty of Oral and Dental Medicine, Kafrelsheikh University

Kafrelsheikh University

研究点 (2)

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