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

Not Applicable

Completed

• Conditions: Stomatognathic Diseases; Periapical Periodontitis; Tooth Diseases
• Interventions: Device: PRF

• Registration Number: NCT02801552
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-16
• Primary Completion: 2019-11
• Study Completion: 2020-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regenerative Endodontic Procedure + PRF	PRF	Visit 1: root canal dressing with triple antibiotic paste. Visit 2: a 5 ml sample of whole blood was drawn intravenously from the patient's forearm. The blood sample is centrifuged at 400 g for 10 min. The prepared PRF membrane is cut into segments, the fragments are placed into the canal space. The coronal is sealed mineral trioxide aggregate and composite resin.

Primary Outcome Measures

Name	Time	Method
Evidence of periapical healing	12 months

Secondary Outcome Measures

Name	Time	Method
Evidence of root development	24 months
Evidence of pulp sensibility	24 months	a positive response to pulp sensibility tests include cold test and electric pulp testing

Trial Locations

Locations (1)

School and Hospital of Stomatology, Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China