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Not yet recruiting NCT07192289

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

No phase Interventional Chronic Apical Periodontitis Necrosis of Pulp Acute Apical Periodontitis of Pulpal Origin Periapical Abscess

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth..
Who it may be relevant to
Registry conditions: Chronic Apical Periodontitis, Necrosis of Pulp, Acute Apical Periodontitis of Pulpal Origin, Periapical Abscess. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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 (single-rooted teeth with necrotic pulp, with or without periapical pathology). The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.

Interventions

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

Primary outcome measures

  • Clinical assessment [Time frame: 1 month, 3 months, 6 months, 9 months, 12 months.]
  • Radiographic assessment [Time frame: 1 month, 3 months, 6 months, 9 months, 12 months]

Eligibility criteria

Inclusion criteria

Participants had a single-rooted tooth with necrotic pulp (negative response to electric pulp testing), with or without periapical pathology (acute apical periodontitis of pulpal origin, chronic periapical periodontitis, periapical abscess with sinus, periapical abscess without sinus), and gave their consent to participate in the study.

Exclusion Criteria: Study samples will be excluded if any of the following criteria are met:

  • 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.
  • The root canal curvature is greater than 25º.
  • The tooth has a periapical cyst or is associated with a jawbone cyst.
  • The tooth has a periodontal pocket deeper than 4 mm.
  • The tooth has no occlusal contact.
  • The patient is pregnant.
  • The patient has diabetes or HIV or other immunocompromised conditions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Odonto-Maxillo-Facial Hospital and University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Identifiers

NCT: NCT07192289 · 3787/QĐ-ĐHYD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗