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

Study Overview
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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.

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

Conditions
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Periapical Periodontitis, Tooth Diseases, Stomatognathic Diseases

Intervention / Treatment
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* Device: PRF


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regenerative Endodontic Procedure + PRF<br>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. | Device: PRF<br>* Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.<br>* Other names: mineral trioxide aggregate;|
| No Intervention: Regenerative Endodontic Procedure<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of periapical healing |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of root development |  | 24 months | 
| Evidence of pulp sensibility | a positive response to pulp sensibility tests include cold test and electric pulp testing | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regenerative endodontic treatment, platelet-rich fibrin, Immature permanent tooth, apical periodontitis