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临床试验/NCT07586228
NCT07586228尚未招募不适用

Hyaluronic Acid With AI-Guided Immediate Implant Placement Using a Modified Socket Shield for Black Triangle Management: A Randomized Controlled Clinical Trial

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年5月10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
32
试验地点
1
主要终点
Interproximal papilla fill

研究概览

简要总结

The Primary aim of this study will be to evaluate the clinical, esthetic, and radiographic outcomes of hyaluronic acid combined with immediate implant placement using AI-assisted and computer guided modified socket shield technique in maxillary anterior sites exhibiting black triangles.

详细描述

The growing patient demand for quicker aesthetic solutions has led oral implantologists to adopt more immediate protocols compared to the delayed approach originally recommended by Brånemark. Studies have shown that implants placed immediately after atraumatic extraction can achieve success rates comparable to those placed in healed sockets. Other findings reported favorable results with immediate implant placement, including reduced resorptive bone changes post-extraction.

Following extraction, the alveolar ridge undergoes changes that often result in bone loss. This is mainly due to the elimination of periodontal ligament attachments and trauma during extraction, with the buccal bone plate being especially affected. Retaining part of the root has been shown to help preserve bone in pontic areas. In 2010, Hürzeler et al. introduced the socket shield technique to mitigate post-extraction bone loss by maintaining the labial portion of the root. Their results indicated stabilized buccal bone height.

Multiple modifications of the socket shield technique have since emerged. Modified socket shield technique (MSST), that involved thinning the labial shield to 1.5 mm, keeping it at the crest level, and leaving the space (jumping gap) between implant and shield without grafting . Some studies highlight the role of grafting this gap in achieving better outcomes. A histological investigation in sheep compared bone healing with and without grafting and found that although bone formed in both cases, the ungrafted bone was structurally weak and had fewer trabeculae, making it unsuitable for supporting masticatory loads.

Human histology showed that this gap could allow soft tissue ingrowth. Currently, there is no definitive human research proving the necessity of grafting in this context. Therefore, Gluckman emphasized the need for further clinical studies to evaluate the benefits of grafting the jumping gap in the MSST protocol.

Artificial intelligence (AI) has transformed digital planning and clinical execution in implant dentistry. AI-based tools analyze CBCT data, segment anatomical structures, identify vital landmarks, and simulate prosthetically driven implant positions with high accuracy. AI can improve implant positioning, angulation, depth control, and proximity to anatomical structures. It reduces surgical errors and improves long-term outcomes.

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

single by the Outcomes Assessor

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (20-50) years old.
  • Single rooted maxillary anterior teeth with hopeless prognosis.
  • Periodontally compromised but with >50% remaining bone.
  • Presence of black triangle ≥2 mm.
  • Systemically healthy.

排除标准

  • Medically compromised patients and systemic conditions that complicate implant placement as uncontrolled diabetes, osteoporosis.
  • Alcoholic and Smokers patients.
  • Pregnant or lactating women.
  • Acute Pathology or infection at implant site
  • Patients with a history of chemotherapy, radiotherapy in head and/or neck region.
  • Patients on bisphosphonate or steroids therapy.

研究组 & 干预措施

Flapless Socket shield technique with AI-based immediate implant placement

Experimental

The root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement

干预措施: Guided socket shield without Hyaluronic acid (Procedure)

Flapless Socket shield technique with AI-based immediate implant placement & Hyaluronic Acid

Experimental

The root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement then 0.2 mL of hyaluronic acid was injected into the interproximal papillary area

干预措施: Guided socket shield with hyaluronic acid (Procedure)

结局指标

主要结局

Interproximal papilla fill

时间窗: 12-months

Using digital photographs the fill of interdental papilla will be assessed

次要结局

  • pink esthetic score(12-months)

研究者

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

Walid Elamrousy

Professor df Periodontology, Faculty of Oral and Dental Medicine, Kafrelsheikh University

Kafrelsheikh University

研究点 (1)

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