Application of Advanced Platelet-Rich Fibrin Plus (A-PRF+) in Revascularisation of Necrotic Immature Permanent Teeth

NCT07092488 | Completed

• 1 other identifier: PRF-CT-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Advanced platelet-rich fibrin plus

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment through 12 months post-treatment

Secondary Outcomes (4)

• Pulp Vitality Responses

  From enrollment through 12 months post-treatment

• Presence of Periapical Pathology

  From enrollment through 12 months post-treatment

• Tooth Survival

  From enrollment through 12 months post-treatment

• Clinical Evaluation of Restorations Using Modified USPHS Criteria

  From enrollment through 12 months post-treatment

Other Outcomes (1)

• Adverse Clinical Events

  From enrollment through 12 months post-treatment

Study Arms (1)

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.

Procedure: Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure

Interventions

Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Procedure 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.

Also known as: Advanced platelet-rich fibrin, A-PRF+ revascularization, Platelet-rich fibrin scaffold, Regenerative endodontic procedure with PRF

Advanced Platelet-Rich Fibrin Plus (A-PRF+) Revascularization Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Department of Pediatric and Preventive Dentistry, University Hospital Centre Zagreb

Zagreb, Croatia, 10000, Croatia

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: While this is an open-label trial with no masking of participants, care providers, investigators, or outcome assessors, radiographic images were randomly coded and evaluated by blinded independent examiners to reduce measurement bias and improve objectivity. Additionally, the control group consisted of randomly selected historical patient records to enhance the validity of comparisons. Follow-up assessments were conducted by independent clinicians who were not involved in the initial treatments, further minimizing examiner bias.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dent. Med.

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: March 19, 2018
• Primary Completion: April 14, 2021
• Study Completion: June 18, 2021
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CR (1)