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临床试验/CTRI/2024/07/070109
CTRI/2024/07/070109招募中不适用

Clinical Comparison of Platelet Rich Fibrin and Collagen Dressing in the Management of Palatal Wounds:A Randomized Controlled Clinical Trial.

Dr Simran C Jaisinghani1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
assess epithelialization of wound

研究概览

简要总结

The hard palate is a common source of soft-tissue grafts (STG) for periodontal and perio-plastic surgery procedures.The main drawbacks of such techniques are the two surgical sites,pain and discomfort experienced by the patient, especially at the donor sites and potential for postoperative bleeding from the donor area which heals by secondary intention resulting in longer healing time and discomfort in the first 2 postoperative weeks.Palatal donor site healing occurs through fibroblast proliferation, collagen synthesis, angiogenesis, and contraction of the wound. In addition, revascularization, immunity, and epithelial cell proliferation are crucial factors for optimal wound healing.In an endeavor to accelerate the healing process and to reduce prolonged bleeding and pain caused by the palatal wound, materials such as hemostatic agents (e.g., absorbable synthetic collagen, absorbable gelatin sponge, cyanoacrylate, oxidized regenerated cellulose, ferric sub sulfate)and more recently platelet concentrate have been used.Collagen dressings have extensively been used in dentistry due to its ability to achieve hemostasis, being chemotactic to fibroblasts and platelets and inducing mesenchymal proliferation and differentiation.These dressing control bleeding and stabilize blood clots as well as protect the wound bed while accelerating the healing process. Platelet-rich fibrin (PRF) is an immune and platelet concentrate collecting on a single fibrin membrane all the constituents of a blood sample favorable to healing and immunity.It has a rich source of growth factors and its application has been reported as an effective way to induce tissue response and regeneration. There are at least 60 different biologically active substances present in platelets which are involved in tissue repair mechanisms such as chemotaxis, cell proliferation and differentiation, angiogenesis, intracellular matrix deposition,immune modulation, antimicrobial activity, and remodeling. Platelet concentrates used in palatal wound healing have growth factors, such as fibroblast growth factor-basic (FGFb),vascular endothelial growth factor (VEGF), and angiopoietin and platelet-derived growth factor (PDGF) which are the main angiogenesis soluble factor. This could facilitate faster healing by exerting a positive influence on the mitogenesis of wound healing cells, angiogenesis, and promotion of cellular differentiation at the wound site.Platelet-rich fibrin supports the three main keys of wound healing mechanism that is “angiogenesis,” “immunity,” and “epithelial proliferation” and thus has implicated its use to protect open wounds and accelerate healing

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 60.00 Year(s)(—)
性别
All

入选标准

  • patients requiring soft tissue grafts( Free gingival graft or de-epithlialised gingival graft) for gingival recession,inadequate keratinized tissue.
  • age between 18-60 years 3) systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation) 4) behavioural factors (no smoking habit) 5) patients willing to participate in the study and willing to sign the informed consent.
  • dental and periodontal factors (a full-mouth plaque score [FMPS] and a full-mouth bleeding score [FMBS] lower than 20% at the time of surgery.

排除标准

  • Systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy) 2) Pregnancy or lactation 3) any uncontrolled systemic disease that might contraindicate periodontal surgery 4) Inability or unwillingness to provide informed consent.

结局指标

主要结局

assess epithelialization of wound

时间窗: 1 week,2 weeks and 1 month

次要结局

  • patient morbidity measures(pain,discomfort and bleeding),healing of palatal wounds(1 week,2 week)

研究者

发起方
Dr Simran C Jaisinghani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nihal Devkar

Sinhgad Dental College and Hospital, Pune

研究点 (1)

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