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NCT Number: NCT07192289

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

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.

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Key information

Conditions

Chronic Apical Periodontitis Abscess Acute Apical Periodontitis of Pulpal Origin Dental Pulp Diseases Dental Pulp Necrosis Infections Jaw Diseases Mouth Diseases Necrosis Necrosis of Pulp Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Abscess Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases Suppuration Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odonto-Maxillo-Facial Hospital and University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Other names: PRF in regenerative endodontic treatment

Primary outcomes

  1. Clinical assessment

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

    • 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.

  2. Radiographic assessment

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

    • 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.

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Collaborators

  • Odonto-Maxillo Facial Hospital in Ho Chi Minh City

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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