Efficacy of i-PRF in regenerative endodontics therapy for mature permanent teeth with pulp necrosis: study protocol for a multicentre randomised controlled trial

Abstract

Background Dental pulp necrosis, a common health problem, is traditionally treated with root canal therapy; however, it fails in restoring the vitality of damaged pulp. Most studies regarding regenerative endodontic therapy (RET) are limited to the treatment of immature necrotic teeth. Given that injectable platelet-rich fibrin (i-PRF) has shown great potential in regenerative medicine as a novel platelet concentration, this study is designed to explore whether i-PRF can serve as a biological scaffold, extending the indications for RET and improving the clinical feasibility of RET in mature permanent teeth with pulp necrosis. Methods This is a randomised, double-blind, controlled, multicentre clinical trial designed to evaluate the clinical feasibility of RET for mature permanent teeth with pulp necrosis and to compare the efficacy of i-PRF and blood clots as scaffolds in RET. A total of 346 patients will be recruited from three centres and randomised at an allocation ratio of 1:1 to receive RET with either a blood clot or i-PRF. The changes in subjective symptoms, clinical examinations, and imaging examinations will be tracked longitudinally for a period of 24 months. The primary outcome is the success rate of RET after 24 months. The secondary outcome is the change in pulp vitality measured via thermal and electric pulp tests. In addition, the incidence of adverse events such as discolouration, reinfection, and root resorption will be recorded for a safety evaluation. Discussion This study will evaluate the clinical feasibility of RET in mature permanent teeth with pulp necrosis, providing information regarding the efficacy, benefits, and safety of RET with i-PRF. These results may contribute to changes in the treatment of pulp necrosis in mature permanent teeth and reveal the potential of i-PRF as a novel biological scaffold for RET. Trial registration ClinicalTrials.govNCT04313010. Registered on 19 March 2020

Are platelet concentrate scaffolds superior to traditional blood clot scaffolds in regeneration therapy of necrotic immature permanent teeth? A systematic review and meta-analysis

“…1). Seven studies were excluded because there were published in non English [44], the included teeth were not immature permanent teeth [17,45], and there was no blood clot in the control group [18,[46][47][48] (Additional file 1). Details on the selection process of articles were represented with a flow diagram (Fig.…”

Ortho-Endo Management of Traumatically Intruded Immature Incisors: A Case Report of Novel Interventional Approach With 20 Months Follow-Up

“…It is often necessary to employ a combination of techniques to achieve optimal results. Liang et al [ 10 ] and Nageh et al [ 11 ] conducted a study on the use of i-PRF as a novel biological scaffold for REP. Our case report used a similar treatment approach, and, to our knowledge, it is the only case report that has used i-PRF in immature teeth. This approach is designed to promote continuous root length thickening and maintain the patient's asymptomatic status.…”

Endodontic Surgical Treatment: Lateral Window Approach and Use Prf. Case Report

“…Since its introduction, PRP has been used in combination with various graft materials in bone augmentation procedures [22][23][24][25][26] . PRF represents a new step in the therapeutic collaboration of platelet gel.…”