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Chronic Apical PeriodontitisNCT07192289

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

A study testing Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth. in people with Chronic Apical Periodontitis and Necrosis of Pulp, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth.
How many people
57 participants
Where
1 siteVietnam
Study dates
15 Sep 2025to 31 Aug 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

VI THI TUONG TRAN, Master of Science contact

84 + 357199931

tuongvitranthi94@gmail.com

Vietnam1 site
  • Odonto-Maxillo-Facial Hospital and University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City, Ho Chi Minh City, 70000

    VI THI TUONG TRAN, Master of Science, 84+ 357199931, tuongvitranthi94@gmail.com

    VI THI TUONG TRAN, Master of Science

Other trials in 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 with necrotic pulp. The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.

Read the 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.

Being tested
Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth.
Keywords
PRF, regenerative endodontic treatment, mature permanent treatment
Medical subject headings
Dental Pulp Necrosis, Periapical Abscess

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called PRF in regenerative endodontic treatment

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192289
Sponsor's protocol ID
3787/QĐ-ĐHYD
Status last verified
Sep 2025
First submitted
7 Sep 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To ensure patient data confidentiality, I do not intend to share the research data with other researchers.

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