Regenerative Endodontic Therapy in Cases of Irreversible Pulpitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorShaheed Zulfiqar Ali Bhutto Medical University

About this trial

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"

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients from both genders with an age range of 18-35 years old.

Permanent teeth with mature roots with a diagnosis of irreversible pulpitis, with absorption damage to the apex, and the diameter of the apical hole is greater than 1 mm.

A restorable tooth.

There is no need to leave space for the final post/core restoration.

Disqualifiers

Patients with other serious organ diseases, such as cardiopulmonary, kidney and other major diseases.

Pregnant women or lactating or expecting within a year.

Patients with apical cysts.

Patients with poor cooperation and those who quit the study halfway.

Trial design

Design model

Parallel

Treatments tested in this trial

  • regenerative endodontic therapy using I-PRF

    Procedure/Surgery

    Blood will be taken from medial cubital vein

  • blood clot

    Procedure/Surgery

    Other: BC According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: regenerative endodontic therapy with blood clotActive comparator 1 intervention
Group B: regenerative endodontic therapy with I-PRFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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