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临床试验/NCT07368621
NCT07368621招募中不适用

Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype: A Randomized Controlled Clinical Trial

British University In Egypt1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年1月16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
38
试验地点
1
主要终点
Gingival thickness

研究概览

简要总结

A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The treatment of thin tissue phenotype should be improved as the thin tissue phenotype will lead to plaque accumulation. There are some techniques that can increase the thickness of the peri-implant mucosa including connective tissue graft, platelet- rich fibrin and xenogeneic collagen matrix .Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants5. It contains various growth factors that are believed to contribute to periodontal regeneration. It promotes neovascularization and accelerated wound closing

详细描述

Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The critical amount of soft tissue thickness on the buccal aspect of implants has been determined to be 2mm. Thick mucosal tissue often has better esthetic outcomes as it creates better tissue contour, mask the metal abutment and creating papilla after prosthesis fabrication. The difference in the amount of bone remodeling is related to the difference in mucosal tissue thickness, which is believed to be the result of supracrestal tissue height establishment. Presence of thin gingival phenotype around dental implant increases the prevalence of peri-implantitis and peri-implant mucositis. Thin gingival phenotype and inadequate keratinized mucosa width lead to greater food impaction compared with thick gingival phenotype and adequate keratinized mucosa. Patients with thin gingival phenotype have more pain and discomfort during oral hygiene therefore making it more difficult for plaque control.

Various techniques are used to increase the thickness of the peri-implant mucosa. These include connective tissue grafts, platelet-rich fibrin and xenogeneic collagen matrix. The volume of labial bone may be maintained by the increased thickness of soft tissue as a result of connective tissue graft . The autologous connective tissue graft has been widely recommended for mucosal tissue thickness enhancement due to its favorable thickness with minimal shrinkage in long-term follow-up when compared to other soft tissue graft approaches. Connective tissue graft (CTG) is considered the gold standard for soft-tissue correction and augmentation surgeries, but involves a secondary donor area and its associated complications. Connective tissue graft (CTG) has become a reliable treatment modality for increasing gingival thickness, width of keratinized gingiva, root coverage, treatment of furcation alveolar ridge deficiencies management of peri-implant tissue abnormalities and papillary loss. The scope of free gingival graft has been narrowed down especially in the esthetic region.

Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Platelet-rich fibrin (PRF) is increasingly becoming popular in dentistry due to its growth factor-secreting properties and is also known to enhance wound healing and soft tissue thickness at the surgical site.

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
Double (Participant, Outcomes Assessor)

盲法说明

Biostatican

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Patients between 18-60 years.
  • With thin gingival phenotype with a peri-implant mucosal thickness of less than 2mm
  • With single missing tooth in the incisor, canine and premolar area. With the presence of two natural adjacent teeth and to not have a bone augmentation procedure before or during the dental implant.
  • 3. Patient consent approval and signing
  • Medically free patients
  • Patients with good oral hygiene
  • Patients free from untreated periodontal disease

排除标准

  • 1. Smokers
  • Psychological problem
  • Systemic disease
  • Poor oral hygiene
  • Patients who previously received radiation therapy of the jaws
  • Patients taking medications that affect healing.

研究组 & 干预措施

Control group

Other

Connective tissue graft (CTG)

干预措施: Connective tissue graft(CTG) (Procedure)

Test group

Active Comparator

Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)

干预措施: Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF) (Procedure)

结局指标

主要结局

Gingival thickness

时间窗: 6 months

Anesthetic needle with a rubber stopper36 Numerical (mm)

次要结局

  • Postoperative pain (direct)(14 days)
  • Width of keratinized mucosa(6 months)

研究者

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

Rania hesham

Demonstrator

British University In Egypt

研究点 (1)

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