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

NCT07192289 | Not Yet Recruiting DMC

• 1 other identifier: 3787/QĐ-ĐHYD
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Apical Periodontitis; Necrosis of Pulp; Acute Apical Periodontitis of Pulpal Origin; Periapical Abscess

Keywords

PRF; regenerative endodontic treatment; mature permanent treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  1 month, 3 months, 6 months, 9 months, 12 months.

• 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.

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

Interventions

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.

Also known as: PRF in regenerative endodontic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• Odonto-Maxillo Facial Hospital in Ho Chi Minh City: collaborator

Study Sites (1)

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

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Abscess

Interventions

proliferation regulatory factors, human urine; Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abscess; Suppuration; Infections; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

VI THI TUONG TRAN, Master of Science

CONTACT

84 + 357199931; tuongvitranthi94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 25, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)