Actively Recruiting
Clinical and Radiographic Outcomes With Injectable Platelet-Rich Fibrin in Mature Permanent Teeth With Symptomatic Irreversible Pulpitis A Randomized Controlled Trial
Led by Shaheed Zulfiqar Ali Bhutto Medical University · Updated on 2024-08-05
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates regenerative endodontic therapy (RET) as a treatment for mature permanent teeth with symptomatic irreversible pulpitis. Traditional root canal therapy (RCT) is widely used but can weaken teeth and lead to higher than expected failure rates. RET, based on tissue engineering concepts involving stem cells, scaffolds, and growth factors, aims to restore damaged tooth structures including dentine and pulp cells, potentially offering a less invasive alternative to RCT. The trial compares two RET procedures: one using a blood clot formed by inducing bleeding past the apical foramen, and the other using injectable platelet-rich fibrin (I-PRF) introduced into the root canal after blood induction. Both methods involve intentionally causing bleeding in the canal to promote regeneration. Blood for I-PRF is collected from a vein, and the treatment is applied to anterior teeth and premolars with single canals. Participants will be adults aged 18 to 35 with mature teeth diagnosed with irreversible pulpitis. Researchers will monitor success through clinical and radiographic outcomes over 12 months, including changes in pulp vitality at multiple intervals. Assessments include evaluating healing potential, tooth restoration, and symptoms. The study involves randomized assignment to treatment groups with single masking and follows patients closely to measure treatment success and safety throughout the year.
CONDITIONS
Brief Title
Regenerative Endodontic Therapy in Cases of Irreversible Pulpitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 35 years old of any gender
- Permanent teeth with mature roots diagnosed with irreversible pulpitis
- Teeth with apical absorption damage and apical hole diameter greater than 1 mm
- Restorable teeth without need for space for final post/core restoration
- Anterior teeth and premolars with a single canal
- Cooperative and compliant patients
- No allergy to drugs or antibiotics required for treatment
- No periodontal disease or root cracking
You will not qualify if you...
- Patients with serious organ diseases such as cardiopulmonary or kidney diseases
- Pregnant, lactating, or planning pregnancy within one year
- Patients with apical cysts
- Patients with poor cooperation or who quit the study midway
- Patients with periodontitis
- Patients with dental dysplasia or genetic oral disorders
- Patients with dental phobia
- Patients with mental disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with follow-up assessments over 12 months
Participants receive regenerative endodontic therapy using either blood clot or injectable platelet-rich fibrin (I-PRF) to treat mature permanent teeth with irreversible pulpitis.
Follow-up visits at 1, 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Dr Shahbaz Saqib
Islamabad, ICT, Pakistan, 44080
Actively Recruiting
Research Team
D
Dr Shahbaz Saqib, BDS
N
Nasar Um Min Allah, BDS,MSD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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