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

NCT ID: NCT02801552

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Periapical Periodontitis Tooth Diseases Stomatognathic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Regenerative Endodontic Procedure + 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.

Group Type EXPERIMENTAL

PRF

Intervention Type DEVICE

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

Regenerative Endodontic Procedure

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRF

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

Intervention Type DEVICE

Other Intervention Names

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mineral trioxide aggregate

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaojing Huang

DDS, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojing Huang, PhD

Role: STUDY_CHAIR

School and Hospital of Stomatology, Fujian Medical University

Locations

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School and Hospital of Stomatology, Fujian Medical University

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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JS14031

Identifier Type: -

Identifier Source: org_study_id

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