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Clinical Trials/NCT02801552
NCT02801552
Completed
Not Applicable

Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial

Fujian Medical University1 site in 1 country60 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periapical Periodontitis
Sponsor
Fujian Medical University
Enrollment
60
Locations
1
Primary Endpoint
Evidence of periapical healing
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.

Detailed Description

The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
February 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fujian Medical University
Responsible Party
Principal Investigator
Principal Investigator

Xiaojing Huang

DDS, PhD, Professor

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

  • Between 6 and 18 years of age
  • Provision of Informed Consent
  • Cooperative in the dental chair
  • Permanent immature teeth with apical periodontitis and incomplete root development

Exclusion Criteria

  • Have a medical history that may complicate treatment
  • Unlikely to be able to comply with the study procedures

Outcomes

Primary Outcomes

Evidence of periapical healing

Time Frame: 12 months

Secondary Outcomes

  • Evidence of root development(24 months)
  • Evidence of pulp sensibility(24 months)

Study Sites (1)

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