Application of Advanced Platelet-Rich Fibrin Plus (A-PRF+) in Revascularisation of Necrotic Immature Permanent Teeth
NCT ID: NCT07092488
Last Updated: 2025-07-30
Study Results
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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COMPLETED
NA
28 participants
INTERVENTIONAL
2018-03-19
2021-06-18
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Group
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.
Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure
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.
Interventions
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Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
8 Years
18 Years
ALL
No
Sponsors
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University of Zagreb
OTHER
Responsible Party
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Dubravka Turjanski, Dr. Dent. Med.
Dr. Dent. Med.
Locations
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Department of Pediatric and Preventive Dentistry, University Hospital Centre Zagreb
Zagreb, Croatia, Croatia
Countries
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Other Identifiers
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PRF-CT-01
Identifier Type: -
Identifier Source: org_study_id
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