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

University of Zagreb

Status: Completed

Conditions: Pulp Regeneration; Root Maturation; Periapical Lesions; Regenerative Endodontic Treatment; Necrotic Immature Permanent Teeth

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07092488

PRF-CT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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