An interventional study of regenerative endodontic therapy using I-PRF and blood clot in Symptomatic Irreversible Pulpitis, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Not applicable, Interventional, and Treatment
Root canal therapy (RCT) is a classical and effective treatment that is currently utilised in dental practice, offering high success rates for pulp and periapical diseases; however, teeth after RCT are susceptible to altered pulp defence and sensory function, even fractures, as a consequence of pulp loss. Furthermore, several studies have highlighted that the actual failure rate of standard root canal treatments performed in general practice is significantly higher than expected . Moreover, these treatments are lengthy and costly and are often subject to retreatment .Inherent in this procedure(rct) is loss of dental hard tissue and subsequent weakening of the treated tooth,making them more prone to fracture. Therefore, less invasive alternative strategies could be used to treat pulpitis, even when irreversible.
Murray et al. proposed the term "Regenerative endodontic treatment (RET)" in 2007, based on a tissue engineering concept (stem cells, biomimetic scaffolds, and bioactive growth factors). The 2016 American Association of Endodontists (AAE) guidelines formally defined RET as a collection of "biologically based procedures designed to replace damaged tooth structures, including dentine and root structures, as well as cells of the pulp-dentine complex"
Mature permanent teeth with Irreversible Pulpitis have traditionally been managed with root canal treatment .However this procedure significantly reduces the survival rate of tooth. Acknowledging the inherent healing potential of an infection-free pulp, attempts have been made to use pulpotomy as a treatment modality in permanent teeth with complete root development exhibiting symptoms of irreversible pulpitis, where the radicular pulp is still healthy. Besides, the issues associated with coronal pulpotomy in permanent teeth are uncertainty on the pulpal status at the time of treatment, and lack of predictability. Moreover, there is a dearth of information in the literature that assesses the healing potential of pulp tissue in terms of clinical and radiographic outcomes in mature teeth with irreversible pulpitis.Regenerative endodontic therapy (RET) has attracted increasing attention with the development of tissue engineering. RET applies the concept of tissue engineering to achieve revascularization, innervation, and restoration of odontoblastic layers. Unlike root canal therapy, the disinfected canals are filled with vital tissue in RET rather than biocompatible, nonvital foreign materials. While several studies have explored the potential of pulp regeneration for infected teeth, most studies are limited to the treatment of immature necrotic teeth . For mature permanent teeth, the vital pulp is also of great importance in enhancing the immune system in root canals, promoting dentin deposition under chronic stimuli, and preventing discolouration. However, most of the reports of pulp regeneration in mature teeth are case reports or case series as mature teeth have fewer stem/progenitor cells, have narrower apical pathways for cell migration, and are more difficult to disinfect. Hence, it is of great urgency to develop an improved RET procedure to maximise the regeneration potential of mature teeth and extend the indications of RET.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 288 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. The adequate blood need to be full with canal space and below the CEJ, then wait for 10-15min to coagulate.
Procedure: blood clot
In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. Only the apex 1/3 of the root canal need to be filled with blood. PRF was injected into the root canal to a level below the CEJ, then wait for 10-15min to coagulate.
Procedure: regenerative endodontic therapy using I-PRF
Blood will be taken from medial cubital vein
Other: BC According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.
Success of regenerative endodontics therapy
Success: Defined as clinical and radiographic assessment of the teeth. Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency.
Time frame: 12 months
Change in pulp vitality
Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in teeth treated with RET.
Time frame: 1、3、6、12 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Jun 2025, 10 months after the start.
Of 158 non-industry interventional studies with no phase under Pulpitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 10 months is below that.
Counting every sponsor, half of 158 studies reached it within 16 months; a quarter within 9 and three quarters within 28.
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Shaheed Zulfiqar Ali Bhutto Medical University