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

NCT ID: NCT07192289

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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 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.

Intervention Type PROCEDURE

Other Intervention Names

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PRF in regenerative endodontic treatment

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Odonto-Maxillo Facial Hospital in Ho Chi Minh City

UNKNOWN

Sponsor Role collaborator

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Tran Thi Tuong Vi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Site Status

Countries

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Vietnam

Central Contacts

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VI THI TUONG TRAN, Master of Science

Role: CONTACT

84 + 357199931

Facility Contacts

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VI THI TUONG TRAN, Master of Science

Role: primary

84+ 357199931

Other Identifiers

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3787/QĐ-ĐHYD

Identifier Type: -

Identifier Source: org_study_id

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