Clinical Research on the Safety Evaluation of Platelet-rich Plasma Treatment in Oral Diseases: A Study Protocol.

ABSTRACT

Background: Platelet-rich plasma (PRP) is a biological product obtained from autologous blood that contains growth factors, promoting the healing and regeneration of human tissues. Several oral diseases require surgical intervention, producing residual wounds that undergo a healing process, accompanied by pain, swelling, superinfections, and bone remodeling. This protocol study aims to evaluate the safety of PRP use for the following dental procedures post-extraction socket healing, periodontal tissue regeneration, maxillary sinus floor elevation, tooth transplantation, and intentional tooth replantation. Methods: Ten patients will be enrolled and subjected to the required treatment with the addition of PRP, after appropriate hematological and biochemical evaluations. The participants will then be subjected to an observation period of 4 weeks to monitor adverse events through clinical observation. Secondary outcomes will regard pain, and clinical evolution of the treated site. Among these, presence of infection, swelling, wound healing, stability of the transplanted tooth. Discussion: Safety of medical procedures represents the first requirement for their introduction in routine practice. A careful evaluation of clinical response during follow-up period and registration of adverse effects is fundamental for safety confirmation and subsequent use of PRP for the proposed dental procedures. Trial registration Japan Registry of Clinical Trials (https//jrct.niph.go.jp/, registry number jRCTc030190273, jRCTc030190274, jRCTc030190275, jRCTc030190276, jRCTc030190277; Date of registration 31 March 2020).