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NCT Number: NCT02801552

Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF

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.

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Key information

Conditions

Periapical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases Tooth Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School and Hospital of Stomatology, Fujian Medical University

Fuzhou, Fujian, 350002, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRF

Device

Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.

Other names: mineral trioxide aggregate

Primary outcomes

  1. Evidence of periapical healing

    Time frame: 12 months

Secondary outcomes

  1. Evidence of root development

    Time frame: 24 months

  2. Evidence of pulp sensibility

    Time frame: 24 months

    a positive response to pulp sensibility tests include cold test and electric pulp testing

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 16, 2016
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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