Clinical trial NCT05305417: Cell-free Autologous Regenerative Endodontics Treatment for Teeth With Periapical Lesions (CARETT)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periapical Diseases
Pulp Necroses
Keywords: Regenerative Endodontics
Permanent Dentition
Pulp Necroses
Periapical Diseases
Root Canal Filling Material
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy of therapy
timeFrame: 12 month
Secondary outcomes:
measure: Tooth re-sensibilization
timeFrame: 3, 6 and 12 month
measure: Tooth re-vitalization
timeFrame: 3, 6 and 12 month
measure: Periapical lesion resolution
timeFrame: 3, 6 and 12 month
measure: Procedure Time
timeFrame: intraoperatory
Other outcomes:
Locations:
Study officials:
affiliation: Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.
name: Alicia Caro, MSC, DDS
role: STUDY_DIRECTOR
affiliation: Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.
name: Juan Caro, DDS
role: PRINCIPAL_INVESTIGATOR
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