Cell-free Autologous Regenerative Endodontics Treatment for Teeth With Periapical Lesions (CARETT)

Study Overview
=================
Brief Summary
-----------------
Conventional endodontic treatment has been the treatment of choice for the management of signs and symptoms of mature permanent teeth with pulpal necrosis and periapical lesion with predictable and favorable results. However, treatment outcomes have not shown improvement or innovation in decades. The main objective of this study is to evaluate the clinical effectiveness of a regenerative endodontic procedure (cell-free and autologous protocol) versus conventional endodontics in the resolution of signs and symptoms of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with a diagnosis of pulpal necrosis and periapical lesion.

Detailed Description
-----------------
Conventional endodontic treatment has been an effective treatment option for decades to treat signs and symptoms in mature permanent teeth with a diagnosis of apical lesion due to pulpal necrosis, allowing the teeth to be kept in the mouth free of signs/symptoms but devitalized. The clinical effectiveness of conventional treatment in this type of case is ≥80%, with some variations according to different studies. Despite advances and modifications in treatment protocols, this therapy has not shown improvements or innovations in its results in recent decades. The Regenerative Endodontics alternative is postulated as a biologically based endodontic treatment option that allows to resolve the signs and symptoms along with dental revitalization through the regeneration of the pulpal connective tissue, generating a substantive possibility of innovation and improvements to the therapy of conventional endodontics. Various regenerative endodontic protocols have been proposed to achieve pulp tissue regeneration, from sophisticated techniques that involve cell transplantation, provision of scaffolds and/or signaling molecules, or simpler protocols that appeal to the autologous capacity of the organism to regenerate tissue. lost. The main objective of this study is to evaluate the clinical effectiveness of a cell-free regenerative endodontic procedure with the contribution of an autologous scaffold (L-PRF) versus conventional endodontics in the recovery of signs of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with diagnosis of pulpal necrosis and periapical lesion.

Official Title
-----------------
Cell-free Autologous Regenerative Endodontics Treatment for Permanent Mature Teeth With Pulp Necrosis and Periapical Lesions: a Randomized, Controlled Phase III Clinical Trial (CARETT)

Conditions
-----------------
Periapical Diseases, Pulp Necroses

Intervention / Treatment
-----------------
* Procedure: Autologous Regenerative Endodontic Treatment
* Procedure: Conventional Root Canal Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female (18-60y) systemically healthy or chronic disease controlled Uniradicular or multiradicular permanent mature teeth Teeth with diagnosis of pulp necrosis (negative response to thermal-cold pulp test) and sings or symptoms (clinical-radiographic) of periapical lesion. Root anatomy with curvatures ≤ 30° Feasibility of adhesive tooth restoration (direct or indirect) Voluntary participation under informed consent Exclusion Criteria: Pregnant or lactating woman Signs of moderate or severe periodontal disease Teeth with signs of radicular fracture (vertical or horizontal), signs of root resorption (endo-exo) teeth with impossibility of good prognosis of coronary rehabilitation by direct or indirect adhesive technique Teeth that to treat can not to be correctly isolate with rubber dam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regenerative Endodontic Treatment<br>This treatment consists of obturated the root canal preparations under an biological-based protocol using autologous biological elements and bioactive materials that allows restore the connective pulp-like tissue within the canals. | Procedure: Autologous Regenerative Endodontic Treatment<br>* The intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an autologous biological scaffold and bioactive biomaterials to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions<br>* Other names: Pulp regeneration;|
| Active Comparator: Conventional root canal treatment<br>This treatment consist on obturated the root canal preparations under the conventional protocol with an inert biomaterials like guttapercha and endodontics cements to seal the root canals. | Procedure: Conventional Root Canal Treatment<br>* The intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an inert biomaterial to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions<br>* Other names: Endodontically-treated Teeth;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of therapy | Number of treated tooth that remain in mouth free of clinical (negative percussion, negative palpation, abscence of inflammation, pain and fistula) and radiographic (total or partial reduction on size of periapical lesion) signs or symptoms at 12 month post operatory. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth re-sensibilization | Number of treated tooth that response positively to thermal pulp sensibility test (cold stimulus) after 3, 6 and 12 months post operatory in relation with the initial negative pulp test. The positive-negative pulp sensibility response of treated teeth first is standardized testing the homologous vital tooth on the mouth. | 3, 6 and 12 month | 
| Tooth re-vitalization | Number of treated tooth that response positively to Vitality Pulp Test Doppler laser flowmetry after 3, 6 and 12 month. This Vitality Test assess pulpal blood flow by the detection of light scatter generated by moving erythrocytes. The positive-negative pulp vitality response of the treated teeth first is standardized testing the homologous vital tooth on the mouth. | 3, 6 and 12 month | 
| Periapical lesion resolution | Resolution of an periapical lesion using Periapical Index (PI), a scoring system for registration of apical periodontitis in radiographs | 3, 6 and 12 month | 
| Procedure Time | total time required to perform each of the therapies recorded in minutes | intraoperatory | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regenerative Endodontics, Permanent Dentition, Pulp Necroses, Periapical Diseases, Root Canal Filling Material