Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

Study Overview
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Brief Summary
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The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.

Detailed Description
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30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.

Official Title
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Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)

Conditions
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Pulp Necroses

Intervention / Treatment
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* Biological: Blood clot scaffold
* Biological: Blood clot scaffold combined with PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Necrotic incisors with immature roots Pulp space not needed for post and core. The patient has to be free from any coagulation disorders, with normal platelets count. Good oral hygiene Cooperative patient Exclusion Criteria: Internal or external root resorption. Root fracture and/or alveolar fracture. Previous root canal treatment. Medically compromised patients Uncooperative patient

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: Induced blood clot scaffold<br> | Biological: Blood clot scaffold<br>* Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction. Biodentine will be placed approximately 3-4 mm below the cementoenamel junction.<br>|
| Experimental: Induced blood clot scaffold combined with Platelet rich fibrin<br> | Biological: Blood clot scaffold combined with PRF<br>* Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 1 month | 
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 3 months | 
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 6 months | 
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 12 months | 
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 1 month | 
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 3 months | 
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 6 months | 
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 12 months | 
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 1 month | 
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 3 months | 
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 6 months | 
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 12 months | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 1 month | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 1 month | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 3 months | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 3 months | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 6 months | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 6 months | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 12 months | 
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regenerative endodontics, Open apex, Immature necrotic teeth