Regenerative Endodontic Therapy in Cases of Irreversible Pulpitis

NCT06525844 | Recruiting

• 1 other identifier: SSaqib
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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"

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

• Change in pulp vitality

  1、3、6、12 months

Study Arms (2)

regenerative endodontic therapy with blood clot

ACTIVE COMPARATOR

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

regenerative endodontic therapy with I-PRF

EXPERIMENTAL

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

Interventions

regenerative endodontic therapy using I-PRF PROCEDURE

Blood will be taken from medial cubital vein

regenerative endodontic therapy with I-PRF

blood clot PROCEDURE

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

regenerative endodontic therapy with blood clot

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Anterior teeth and premolars with single canal.
• A cooperative and compliant patient.
• Patients not allergic to the drugs and antibiotics which needed to complete treatment.
• No periodontal disease or root cracking.

You may not qualify if:

• 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.
• Patients with periodontitis.
• Patients with dental dysplasia or other oral genetic disorders.
• Patients with dental phobia.
• Patients with mental disorders.

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Dr Shahbaz Saqib

Islamabad, ICT, 44080, Pakistan

RECRUITING

MeSH Terms

Interventions

Blood Coagulation

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dr Shahbaz Saqib, BDS

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Shahbaz Saqib, BDS

CONTACT

3092497829; shahbazbds@outlook.com

Nasar Um Min Allah, BDS,MSD

CONTACT

3349586057; nz.zulfiqarali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)