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.
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
- Conditions the study is for
- Chronic Apical Periodontitis, Necrosis of Pulp, Acute Apical Periodontitis of Pulpal Origin
- 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.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
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
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.
- Conditions
- Chronic Apical Periodontitis, Necrosis of Pulp, Acute Apical Periodontitis of Pulpal Origin, Periapical Abscess
- 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.
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.
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.
- First posted25 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Odonto-Maxillo Facial Hospital in Ho Chi Minh City
- Responsible party
- Principal investigator, Tran Thi Tuong Vi, University of Medicine and Pharmacy at Ho Chi Minh City
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
- ClinicalTrials.gov ID
- NCT07192289
- Acronym / sponsor ID
- 3787/QĐ-ĐHYD
- Conditions
- Chronic Apical Periodontitis, Necrosis of Pulp, Acute Apical Periodontitis of Pulpal Origin, Periapical Abscess
- Keywords
- PRF, regenerative endodontic treatment, mature permanent treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Odonto-Maxillo Facial Hospital in Ho Chi Minh City
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- 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).
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using advanced platelet-rich fibrin (A-PRF+) or injectable platelet-rich fibrin (i-PRF) in regenerative endodontic treatment in mature permanent teeth.Also: PRF in regenerative endodontic treatmentAfter 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. | Procedure or surgery | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. To ensure patient data confidentiality, I do not intend to share the research data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VI THI TUONG TRAN, Master of Science (84 + 357199931, tuongvitranthi94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment (time frame: 1 month, 3 months, 6 months, 9 months, 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.