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

NCT07092488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-07-30

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2021-04-14
Completion
2021-06-18

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07092488 on ClinicalTrials.gov