Necrotic Immature Permanent TeethA-PRF+NCT07092488
Application of Advanced Platelet-Rich Fibrin Plus (A-PRF+) in Revascularisation of Necrotic Immature Permanent Teeth
A study testing Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure in people with Necrotic Immature Permanent Teeth and Regenerative Endodontic Treatment, run by University of Zagreb at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of an advanced platelet-rich fibrin plus (A-PRF+) revascularization procedure to promote healing and root development in necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Necrotic Immature Permanent Teeth, Regenerative Endodontic Treatment, Pulp Regeneration
- What is being tested?
- Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCroatia
- Study dates
- 19 Mar 2018to 18 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 8 to 18 years presenting with immature permanent single-rooted teeth with necrotic pulp caused by caries or dental trauma
- Preserved tooth crown
- Negative response to cold and electric pulp tests
- Radiographic evidence of incomplete root development (Cvek stages I-IV)
- Apical diameter greater than 0.5 mm
Who cannot join
- Presence of systemic illness or allergies to treatment components
- Complicated crown or root fractures
- Evidence of ankylosis or root resorption
- Ongoing orthodontic treatment
- Inability to comply with follow-up appointments (e.g., needle phobia or poor cooperation)
- Subsequent trauma to the treated tooth during the study period
- Missed recall appointments
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Department of Pediatric and Preventive Dentistry, University Hospital Centre Zagreb
Zagreb, Croatia, 10000
About this study
Official title: Application of Platelet-Rich Fibrin (PRF) in Revascularisation of Immature Permanent Teeth
The goal of this clinical trial is to evaluate the effectiveness of an advanced platelet-rich fibrin plus (A-PRF+) revascularization procedure to promote healing and root development in necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years.
The main questions it aims to answer are:
Read more
- Does the A-PRF+ protocol improve root length, dentinal wall thickness, and apical closure compared to traditional calcium hydroxide apexification treatment?
- Does A-PRF+ promote restoration of pulp vitality and reduce clinical symptoms such as pain, inflammation, or tooth discoloration? Results from the A-PRF+ treatment group will be compared with those from a historical control group receiving traditional calcium hydroxide apexification to evaluate relative effectiveness.
Participants will:
- Receive treatment following the A-PRF+ protocol, which includes disinfecting the tooth canal, applying an autologous platelet-rich fibrin scaffold, and sealing with glass ionomer cement;
- Undergo clinical and radiographic follow-up visits at 1, 3, 6, 9, and 12 months;
- Have pulp vitality tested with cold, electric, and laser Doppler flowmetry methods;
- Be monitored for clinical symptoms, healing progress, and restoration performance.
This study will help determine whether A-PRF+ is a safe and effective alternative to conventional apexification for regenerating necrotic immature teeth in young patients.
Read the detailed description
This study is a prospective interventional clinical trial evaluating an advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol compared to a historical control group treated with traditional calcium hydroxide apexification for necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years.
The main goal is to assess the regenerative effectiveness of the A-PRF+ protocol in promoting root development, including root lengthening, dentinal wall thickening, and apical closure, compared to conventional apexification. Secondary objectives include evaluating pulp vitality restoration and monitoring clinical outcomes such as symptom resolution, tooth survival, and adverse effects like tooth discoloration.
Participants in the experimental group were prospectively enrolled and received treatment involving minimal mechanical instrumentation, canal disinfection with sodium hypochlorite, intracanal calcium hydroxide medicament, followed by triple antibiotic paste. At the final appointment, autologous A-PRF+ was prepared from peripheral blood and applied as an intracanal scaffold extending into the coronal cavity, sealed permanently with glass ionomer cement.
The control group consists of patients previously treated at the same institution with calcium hydroxide apexification. Their clinical and radiographic records were retrospectively reviewed for comparison. Apexification was not performed as part of this study.
Clinical and radiographic follow-ups were conducted at 1, 3, 6, 9, and 12 months, including pulp vitality testing with cold, electric, and laser Doppler flowmetry methods, along with standardized periapical radiographs to measure root length, dentinal wall thickness, and apical diameter. Restoration quality was assessed using modified USPHS criteria.
This study aims to determine if the A-PRF+ protocol provides a safe and effective regenerative alternative to traditional apexification for treating necrotic immature teeth, potentially enhancing long-term tooth preservation in pediatric patients.
- Conditions
- Necrotic Immature Permanent Teeth, Regenerative Endodontic Treatment, Pulp Regeneration, Root Maturation, Periapical Lesions
- Being tested
- Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure
- Keywords
- Advanced platelet-rich fibrin, Regenerative endodontics, Immature permanent teeth, Apexification, Calcium hydroxide, Dental pulp regeneration, Revascularization, Platelet-rich fibrin, Advanced platelet-rich fibrin plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization ProcedureProcedure or surgery
Also called Advanced platelet-rich fibrin, A-PRF+ revascularization, Platelet-rich fibrin scaffold, Regenerative endodontic procedure with PRF
The intervention consists of the advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol. It includes minimal mechanical instrumentation of the root canal, disinfection using sodium hypochlorite irrigation, and intracanal medicaments-initially calcium hydroxide followed by triple antibiotic paste. Peripheral venous blood was drawn from each participant into anticoagulant-free sterile tubes. The blood was immediately centrifuged at 1300 rpm for 8 minutes to obtain the A-PRF+ clot, which was then used as the scaffold material, extending through the root canal into the coronal cavity. The cavity was permanently sealed with glass ionomer cement. This protocol aims to promote regenerative healing and continued root development in necrotic immature permanent teeth.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Group | Experimental | Participants receive the advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol. This involves minimal mechanical instrumentation, canal disinfection with sodium hypochlorite, intracanal medicaments including calcium hydroxide and triple antibiotic paste, followed by placement of autologous A-PRF+ scaffold extending into the coronal cavity. The cavity is then permanently sealed with glass ionomer cement. Receives: Procedure: Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Lengthening
Root lengthening was assessed by measuring the linear distance from the cementoenamel junction (CEJ) to the radiographic apex on standardized periapical radiographs. Radiographs were obtained using a film holder to ensure consistent angulation and minimize distortion. Measurements were performed using diagnostic software with a precision of 0.1 mm by two independent blinded examiners. The change from baseline to follow-up measurements over the 12-month period was calculated to quantify root lengthening.
Measured: From enrollment through 12 months post-treatment
Dentinal Wall Thickening
Dentinal wall thickening was evaluated by measuring the increase in dentinal wall width at the coronal two-thirds of the root on standardized periapical radiographs. Radiographs were obtained using a film holder to ensure reproducible angulation and reduce distortion. Two blinded examiners independently performed measurements using diagnostic software with an accuracy of 0.1 mm. The difference between baseline and follow-up measurements over 12 months quantified dentinal wall thickening.
Measured: From enrollment through 12 months post-treatment
Apical Closure
Apical closure was assessed by measuring the reduction in apical diameter on standardized periapical radiographs. Radiographs were consistently acquired using a film holder to minimize angulation differences and distortion. Two independent blinded examiners used diagnostic software with 0.1 mm precision to measure the distance across the apical foramen. Changes from baseline to follow-up at 12 months were used to quantify apical closure.
Measured: From enrollment through 12 months post-treatment
Secondary outcomes (4)
Pulp Vitality Responses
Pulp vitality was assessed at each follow-up visit using cold testing and electric pulp testing on the treated tooth and contralateral control tooth. Laser Doppler flowmetry was performed once per patient at either the 9- or 12-month recall to quantitatively measure pulpal blood flow, indicating revascularization. All tests were performed by clinicians blinded to treatment allocation, with responses recorded as positive or negative.
Measured: From enrollment through 12 months post-treatment
Presence of Periapical Pathology
Presence or absence of periapical lesions was evaluated on standardized periapical radiographs at baseline and follow-up visits. Two blinded examiners independently assessed images for periapical pathology. Changes in lesion presence were recorded throughout the 12-month follow-up.
Measured: From enrollment through 12 months post-treatment
Tooth Survival
Tooth survival was defined as retention of the treated tooth throughout the 12-month follow-up period. Any tooth loss or extraction was recorded as an event. Survival status was assessed during clinical recall visits.
Measured: From enrollment through 12 months post-treatment
Clinical Evaluation of Restorations Using Modified USPHS Criteria
Clinical performance of glass ionomer cement restorations was assessed at each recall visit using Modified United States Public Health Service (USPHS) criteria. Parameters evaluated included retention, marginal discoloration, anatomic form, marginal adaptation, secondary caries, and surface texture. Each parameter was scored as Alpha (clinically excellent), Bravo (clinically acceptable), or Charlie (clinically unacceptable/failure).
Measured: From enrollment through 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start19 Mar 2018
- Primary completion14 Apr 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Immature Permanent TeethStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-group interventional study evaluating the regenerative effectiveness of an advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol in necrotic immature permanent single-rooted teeth. Participants receive the A-PRF+ treatment without randomization or concurrent control groups. The control comparison is conducted retrospectively using historical patient records treated with calcium hydroxide apexification.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dubravka Turjanski, Dr. Dent. Med., University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092488
- Sponsor's protocol ID
- PRF-CT-01
- Acronym
- A-PRF+
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Platelet-Rich Fibrin (PRF) in Revascularisation of Immature Permanent Teeth
- ClinicalTrials.gov ID
- NCT07092488
- Acronym / sponsor ID
- A-PRF+ / PRF-CT-01
- Conditions
- Necrotic Immature Permanent Teeth, Regenerative Endodontic Treatment, Pulp Regeneration, Root Maturation, Periapical Lesions
- Keywords
- Advanced platelet-rich fibrin, Regenerative endodontics, Immature permanent teeth, Apexification, Calcium hydroxide, Dental pulp regeneration, Revascularization, Platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 30 Jul 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.
The goal of this clinical trial is to evaluate the effectiveness of an advanced platelet-rich fibrin plus (A-PRF+) revascularization procedure to promote healing and root development in necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years.
The main questions it aims to answer are:
- Does the A-PRF+ protocol improve root length, dentinal wall thickness, and apical closure compared to traditional calcium hydroxide apexification treatment?
- Does A-PRF+ promote restoration of pulp vitality and reduce clinical symptoms such as pain, inflammation, or tooth discoloration? Results from the A-PRF+ treatment group will be compared with those from a historical control group receiving traditional calcium hydroxide apexification to evaluate relative effectiveness.
Participants will:
- Receive treatment following the A-PRF+ protocol, which includes disinfecting the tooth canal, applying an autologous platelet-rich fibrin scaffold, and sealing with glass ionomer cement;
- Undergo clinical and radiographic follow-up visits at 1, 3, 6, 9, and 12 months;
- Have pulp vitality tested with cold, electric, and laser Doppler flowmetry methods;
- Be monitored for clinical symptoms, healing progress, and restoration performance.
This study will help determine whether A-PRF+ is a safe and effective alternative to conventional apexification for regenerating necrotic immature teeth in young patients.
Detailed description
This study is a prospective interventional clinical trial evaluating an advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol compared to a historical control group treated with traditional calcium hydroxide apexification for necrotic immature permanent single-rooted teeth in children and adolescents aged 8 to 18 years.
The main goal is to assess the regenerative effectiveness of the A-PRF+ protocol in promoting root development, including root lengthening, dentinal wall thickening, and apical closure, compared to conventional apexification. Secondary objectives include evaluating pulp vitality restoration and monitoring clinical outcomes such as symptom resolution, tooth survival, and adverse effects like tooth discoloration.
Participants in the experimental group were prospectively enrolled and received treatment involving minimal mechanical instrumentation, canal disinfection with sodium hypochlorite, intracanal calcium hydroxide medicament, followed by triple antibiotic paste. At the final appointment, autologous A-PRF+ was prepared from peripheral blood and applied as an intracanal scaffold extending into the coronal cavity, sealed permanently with glass ionomer cement.
The control group consists of patients previously treated at the same institution with calcium hydroxide apexification. Their clinical and radiographic records were retrospectively reviewed for comparison. Apexification was not performed as part of this study.
Clinical and radiographic follow-ups were conducted at 1, 3, 6, 9, and 12 months, including pulp vitality testing with cold, electric, and laser Doppler flowmetry methods, along with standardized periapical radiographs to measure root length, dentinal wall thickness, and apical diameter. Restoration quality was assessed using modified USPHS criteria.
This study aims to determine if the A-PRF+ protocol provides a safe and effective regenerative alternative to traditional apexification for treating necrotic immature teeth, potentially enhancing long-term tooth preservation in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-group interventional study evaluating the regenerative effectiveness of an advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol in necrotic immature permanent single-rooted teeth. Participants receive the A-PRF+ treatment without randomization or concurrent control groups. The control comparison is conducted retrospectively using historical patient records treated with calcium hydroxide apexification.
| Arm | Type | Receives |
|---|---|---|
| Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Group | Experimental | Procedure: Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization ProcedureParticipants receive the advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol. This involves minimal mechanical instrumentation, canal disinfection with sodium hypochlorite, intracanal medicaments including calcium hydroxide and triple antibiotic paste, followed by placement of autologous A-PRF+ scaffold extending into the coronal cavity. The cavity is then permanently sealed with glass ionomer cement. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged 8 to 18 years presenting with immature permanent single-rooted teeth with necrotic pulp caused by caries or dental trauma
- Preserved tooth crown
- Negative response to cold and electric pulp tests
- Radiographic evidence of incomplete root development (Cvek stages I-IV)
- Apical diameter greater than 0.5 mm
Key exclusion criteria (7 listed)
- Presence of systemic illness or allergies to treatment components
- Complicated crown or root fractures
- Evidence of ankylosis or root resorption
- Ongoing orthodontic treatment
- Inability to comply with follow-up appointments (e.g., needle phobia or poor cooperation)
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 |
|---|---|---|
| Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization ProcedureAlso: Advanced platelet-rich fibrin, A-PRF+ revascularization, Platelet-rich fibrin scaffold, Regenerative endodontic procedure with PRFThe intervention consists of the advanced platelet-rich fibrin plus (A-PRF+) revascularization protocol. It includes minimal mechanical instrumentation of the root canal, disinfection using sodium hypochlorite irrigation, and intracanal medicaments-initially calcium hydroxide followed by triple antibiotic paste. Peripheral venous blood was drawn from each participant into anticoagulant-free sterile tubes. The blood was immediately centrifuged at 1300 rpm for 8 minutes to obtain the A-PRF+ clot, which was then used as the scaffold material, extending through the root canal into the coronal cavity. The cavity was permanently sealed with glass ionomer cement. This protocol aims to promote regenerative healing and continued root development in necrotic immature permanent teeth. | Procedure or surgery | Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Group |
Primary outcome
Root Lengthening
Time frame: From enrollment through 12 months post-treatment
Root lengthening was assessed by measuring the linear distance from the cementoenamel junction (CEJ) to the radiographic apex on standardized periapical radiographs. Radiographs were obtained using a film holder to ensure consistent angulation and minimize distortion. Measurements were performed using diagnostic software with a precision of 0.1 mm by two independent blinded examiners. The change from baseline to follow-up measurements over the 12-month period was calculated to quantify root lengthening.
Dentinal Wall Thickening
Time frame: From enrollment through 12 months post-treatment
Dentinal wall thickening was evaluated by measuring the increase in dentinal wall width at the coronal two-thirds of the root on standardized periapical radiographs. Radiographs were obtained using a film holder to ensure reproducible angulation and reduce distortion. Two blinded examiners independently performed measurements using diagnostic software with an accuracy of 0.1 mm. The difference between baseline and follow-up measurements over 12 months quantified dentinal wall thickening.
Apical Closure
Time frame: From enrollment through 12 months post-treatment
Apical closure was assessed by measuring the reduction in apical diameter on standardized periapical radiographs. Radiographs were consistently acquired using a film holder to minimize angulation differences and distortion. Two independent blinded examiners used diagnostic software with 0.1 mm precision to measure the distance across the apical foramen. Changes from baseline to follow-up at 12 months were used to quantify apical closure.
4 secondary outcomes
Pulp Vitality Responses
Time frame: From enrollment through 12 months post-treatment
Presence of Periapical Pathology
Time frame: From enrollment through 12 months post-treatment
Tooth Survival
Time frame: From enrollment through 12 months post-treatment
Clinical Evaluation of Restorations Using Modified USPHS Criteria
Time frame: From enrollment through 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure in people with Necrotic Immature Permanent Teeth and Regenerative Endodontic Treatment, run by University of Zagreb at 1 site in Croatia.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jul 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 Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Lengthening (time frame: From enrollment through 12 months post-treatment). The study lists 3 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 30 Jul 2025.