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临床试验/NCT07023757
NCT07023757Enrolling By Invitation不适用

Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP

University of Michigan1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年6月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
44
试验地点
1
主要终点
Soft tissue dimension changes

研究概览

简要总结

This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.

详细描述

Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range: 20 to 80 years.
  • •Patients must require tooth extraction (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
  • •Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers)
  • •Patients interested in implant placement following tooth extraction.

排除标准

  • •Allergies or hypersensitivities to study related medications.
  • •Hematologic disorders/blood dyscrasias.
  • •Active infectious diseases of any kind.
  • •Liver or kidney dysfunction/failure.
  • •Uncontrolled diabetes (HbA1c > 8).
  • •Active cancer treatment - such as active chemotherapy or radiation therapy.
  • •Taking medications that will affect their bone healing (for example, bisphosphonates, Long-term NSAIDs use, Steroid).
  • •Metabolic bone diseases that affect bone healing such as osteoporosis.
  • •Pregnant or lactating women (self-reported).
  • •Smoke 10 or more cigarettes per day (self-reported).
  • •Poor oral hygiene.
  • •Systemic diseases that compromise the immune system
  • •Anti-coagulant therapy

研究组 & 干预措施

Platelet-rich fibrin group.

Active Comparator

Following extraction, a Platelet-rich fibrin plug will be placed in the extraction socket and covered with a collagen plug.

干预措施: Socket preservation (Procedure)

Collagen plug only

Sham Comparator

Collagen plug only

干预措施: Socket preservation (Procedure)

结局指标

主要结局

Soft tissue dimension changes

时间窗: 4 months

Digitally measured soft tissue changes in mm\^2 using intraoral scans

Alveolar ridge dimension changes

时间窗: 4 months

Digitally measured alveolar ridge dimension changes in mm\^2 using cone-beam computed tomography

次要结局

  • Histological bone density.(4 months)
  • Presence of bone turnover proteins.(4 months)
  • Amount of growth factors(At baseline surgery)
  • Wound healing index(1 week, 2 weeks, 4 weeks, and 8 weeks)

研究者

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

Muhammad Saleh

Clinical Assistant Professor, Periodontics and Oral Medicine

University of Michigan

研究点 (1)

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