Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

This study aims to evaluate the antibacterial effects of injectable platelet-rich fibrin (i-PRF) in vitro, and to assess the clinical and radiographic outcomes of using advanced platelet-rich fibrin (A-PRF+) and i-PRF in regenerative endodontic treatment of mature permanent teeth with necrotic pulp. The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

The tooth has had previous endodontic treatment.

The root apex is not fully developed, or there is root resorption/cracking/fracture.

The tooth has severe tooth loss and is indicated for extraction, or is indicated for restoration with a post or cast core after endodontic treatment.

The root canal is calcified.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth.

    Procedure/Surgery

    After obtaining informed consent, the study will be conducted over 2 appointments, 2-4 weeks apart. The first appointment will focus on infection control and inflammation reduction. The canal will be instrumented with a single-file system. The canal will be then irrigated sequentially with 3% sodium hypochlorite (NaOCl), saline, and 17% ethylenediaminetetraacetic Acid (EDTA) to ensure thorough disinfection. Finally, a temporary filling of Glass Ionomer Cement will be placed over an intracanal dressing of calcium hydroxide. At the second appointment, the final treatment will be performed based on the patient's group: Control Group - Blood clot method for regenerative endodontics. Experimental Group 1 - Regenerative endodontics using advanced platelet-rich fibrin (A-PRF+). Experimental Group 2 - Regenerative endodontics using injectable platelet-rich fibrin (i-PRF). All three groups will be then sealed with mineral trioxide aggregate (MTA) and a final composite resin filling.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clinical assessment

* Clinical success: Absence of all the following symptoms (swelling, sinus tract, pain on percussion/bite, tooth mobility, and positive pulp sensibility). * Clinical failure: Presence of any one of the above symptoms.

Time frame
1 month, 3 months, 6 months, 9 months, 12 months.
2

Radiographic assessment

* Radiographic success: Absence or reduction of periapical pathology, measured by change in lesion size on periapical radiographs/CBCT. * Radiographic failure: Persistence or progression of periapical pathology, measured by change in lesion size on periapical radiographs/CBCT.

Time frame
1 month, 3 months, 6 months, 9 months, 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Medicine and Pharmacy at Ho Chi Minh City

Lead sponsor

Odonto-Maxillo Facial Hospital in Ho Chi Minh City

Collaborator

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