Clinical trial

The Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth With Periapical Lesion Using Platelet-rich Fibrin Versus Induced Bleeding: Randomized Clinical Trial

Name
KingAbdullahUH2
Description
Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration. However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks. A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF). This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS.
Trial arms
Trial start
2023-04-01
Estimated PCD
2025-12-01
Trial end
2027-12-01
Status
Recruiting
Treatment
induced bleeding
revascularization of tooth is achieved by induced bleeding
Arms:
Induced bleeding group
plasma rich fibrin
revascularization of tooth is achieved by plasma rich fibrin
Arms:
Platelet-rich fibrin (PRF) group
Size
50
Primary endpoint
Complete healing
treated teeth will be evaluated from start of intervention up to 100 months
Eligibility criteria
Inclusion Criteria 1. Anterior or posterior mature tooth diagnosed with necrotic pulp in the presence of a periapical lesion, 2. Pulp space is not needed for post and core restoration. 3. Patients are not allergic to the medicaments necessary to complete the procedure. Exclusion Criteria 1. Medically compromised patient. 2. Patient with generalized chronic periodontitis. 3. Teeth with previous root canal treatment. 4. Periodontal pocket larger than 3mm. 5. Teeth with vertical fractures 6. Non-restorable teeth
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-04

1 organization

2 products

1 indication