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

Tooth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801552
• Other study ID #: JS14031
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: February 2020

Study information

• Verified date: September 2021
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis
• Stomatognathic Diseases
• Tooth Diseases

Intervention

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

Locations

Country	Name	City	State
China	School and Hospital of Stomatology, Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of periapical healing		12 months
Secondary	Evidence of root development		24 months
Secondary	Evidence of pulp sensibility	a positive response to pulp sensibility tests include cold test and electric pulp testing	24 months