Regenerative treatment for irreversible pulpitis in mature teeth
Clinical and Radiographic Outcomes With the Use of I-PRF in Mature Permanent Teeth With Symptomatic Irreversible Pulpitis : A Randomized Control Trial
NA · Shaheed Zulfiqar Ali Bhutto Medical University · NCT06525844
This study is testing a new way to treat irreversible pulpitis in mature teeth using regenerative therapy to see if it can help teeth heal better than traditional root canals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Shaheed Zulfiqar Ali Bhutto Medical University (other) |
| Locations | 1 site (Islamabad, ICT) |
| Trial ID | NCT06525844 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of regenerative endodontic therapy (RET) as an alternative to traditional root canal treatment for patients with irreversible pulpitis. The approach utilizes a combination of I-PRF (injectable platelet-rich fibrin) and blood clot to promote the healing and regeneration of pulp tissue in mature permanent teeth. By focusing on revascularization and restoration of vital pulp, the study aims to enhance tooth survival rates and reduce the risks associated with conventional treatments. The trial will assess clinical and radiographic outcomes to evaluate the success of this innovative treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18-35 with permanent teeth exhibiting irreversible pulpitis and no significant dental or systemic health issues.
Not a fit: Patients with serious organ diseases, periodontal disease, or those with dental phobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the healing and longevity of teeth affected by irreversible pulpitis, reducing the need for more invasive procedures.
How similar studies have performed: While regenerative endodontic therapy has shown promise in treating immature necrotic teeth, this approach for mature teeth is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Islamabad, ICT
- Dr Shahbaz Saqib — Islamabad, ICT, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Dr Shahbaz Saqib, BDS — Shaheed Zulfiqar Ali Bhutto Medical University
- Study coordinator: Dr Shahbaz Saqib, BDS
- Email: shahbazbds@outlook.com
- Phone: 3092497829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Symptomatic Irreversible Pulpitis