search
Back to results

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

Primary Purpose

Periapical Periodontitis, Tooth Diseases, Stomatognathic Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PRF
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring regenerative endodontic treatment, platelet-rich fibrin, Immature permanent tooth, apical periodontitis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School and Hospital of Stomatology, Fujian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Regenerative Endodontic Procedure + PRF

Regenerative Endodontic Procedure

Arm Description

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.

Regenerative Endodontic Procedure Visit 1: root canal dressing with triple antibiotic paste. Visit 2: Blood clot formation is induced in the root canal after disinfection. No PRF was used in this group. Then the canal access is sealed with mineral trioxide aggregate and composite resin.

Outcomes

Primary Outcome Measures

Evidence of periapical healing

Secondary Outcome Measures

Evidence of root development
Evidence of pulp sensibility
a positive response to pulp sensibility tests include cold test and electric pulp testing

Full Information

First Posted
June 12, 2016
Last Updated
September 2, 2021
Sponsor
Fujian Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02801552
Brief Title
Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF
Official Title
Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis, Tooth Diseases, Stomatognathic Diseases
Keywords
regenerative endodontic treatment, platelet-rich fibrin, Immature permanent tooth, apical periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regenerative Endodontic Procedure + PRF
Arm Type
Experimental
Arm Description
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.
Arm Title
Regenerative Endodontic Procedure
Arm Type
No Intervention
Arm Description
Regenerative Endodontic Procedure Visit 1: root canal dressing with triple antibiotic paste. Visit 2: Blood clot formation is induced in the root canal after disinfection. No PRF was used in this group. Then the canal access is sealed with mineral trioxide aggregate and composite resin.
Intervention Type
Device
Intervention Name(s)
PRF
Other Intervention Name(s)
mineral trioxide aggregate
Intervention Description
Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.
Primary Outcome Measure Information:
Title
Evidence of periapical healing
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evidence of root development
Time Frame
24 months
Title
Evidence of pulp sensibility
Description
a positive response to pulp sensibility tests include cold test and electric pulp testing
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojing Huang, PhD
Organizational Affiliation
School and Hospital of Stomatology, Fujian Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
School and Hospital of Stomatology, Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350002
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs