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临床试验/CTRI/2025/12/099351
CTRI/2025/12/099351尚未招募不适用

Comparative assessment of efficacy of Free Gingival Grafts and Platelet Rich Fibrin Plugs on soft tissue and hard tissue changes in Immediate Implant Placement in the Aesthetic Zone A Randomized Controlled Clinical Trial

DR DEBOPAM SEN1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

Tooth loss in the aesthetic zone critically affects facial harmony and psychological well-being. Consequently, reconstruction must address both functional rehabilitation and highly demanding aesthetic expectations . Current evidence indicates that immediate implant placement at the time of tooth extraction is as predictable as placement in healed sites, while additionally offering advantages such as greater patient acceptance, reduced edentulous periods, and shorter overall treatment time . In aesthetically sensitive areas, immediate implants play a key role in preserving soft tissue contours and alveolar bone dimensions .

Following implant placement, the peri-implant mucosa that develops during healing behaves in an analogous manner to the biological width around natural teeth, forming a protective soft tissue seal . Early establishment of a stable mucosal barrier is therefore crucial for safeguarding peri-implant hard and soft tissues, especially in the aesthetic zone where tissue visibility strongly influences treatment planning and outcomes . Most dimensional changes of the alveolar ridge occur within the first three months after tooth extraction , during which marked horizontal and vertical bone loss can occur, often necessitating additional corrective procedures.

Peri-implant health is typically assessed using clinical and radiographic parameters such as bleeding on probing (BOP), probing depth (PD), and marginal peri-implant bone levels. Within this context, the presence and quality of keratinized attached mucosa (KAM) around implants has emerged as a key factor. A substantial body of literature demonstrates that a KAM width of less than 2 mm is associated with increased plaque accumulation, inflammation, soft tissue recession, and marginal bone loss. While patient-centred outcomes have been less frequently investigated, clinical experience from private periodontal practice suggests that patients report greater comfort and less pain during tooth brushing when a firm band of keratinized tissue surrounds the implant . Overall, an adequate width of KAM supports improved tissue stability, reduced peri-implant inflammation, and superior aesthetic integration.

Soft tissue augmentation around dental implants can be performed at various stages (before, during, or after implant placement) using several surgical techniques and biomaterials. Many authors recommend performing soft tissue corrective procedures before the restorative phase to reduce the risk of biological complications such as mucositis and peri-implantitis and to enhance long-term peri-implant stability . Peri-implant plastic surgery is therefore not only important for achieving optimal pink aesthetics, but also for improving patient-centered outcomes, including comfort and ease of oral hygiene

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • SYSTEMICALLY HEALTHY HUMAN VOLUNTEERS WITH THE FOLLOWING CRITERIA A single hopeless/non-restorable tooth candidate for extraction in the maxillary or mandibular anteriors and premolars in need of a single implant-supported fixed prosthetic rehabilitation The presence of the intact walls of the socket after tooth extraction.
  • The distance between the interdental bone crest and buccal bone crest less than or equal to 3 mm after tooth extraction.
  • Patient with good oral hygiene.

排除标准

  • General contraindications for dental and or surgical treatments.
  • Inflammatory and autoimmune disease of the oral cavity.
  • Uncontrolled diabetes.
  • Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
  • Concurrent or previous radiotherapy of head area.
  • Smokers (more than 10 cigarettes a day).
  • Pregnancy; or lactating women.

研究者

发起方
DR DEBOPAM SEN
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR DEBOPAM SEN

Vokkaligara Sangha Dental College and Hospital

研究点 (1)

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