Cell-free Autologous Regenerative Endodontics Treatment for Permanent Mature Teeth With Pulp Necrosis and Periapical Lesions: a Randomized, Controlled Phase III Clinical Trial (CARETT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periapical Diseases
- Sponsor
- Universidad de Valparaiso
- Enrollment
- 228
- Primary Endpoint
- Efficacy of therapy
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Efficacy of therapy
Time Frame: 12 month
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.
Secondary Outcomes
- Periapical lesion resolution(3, 6 and 12 month)
- Tooth re-sensibilization(3, 6 and 12 month)
- Tooth re-vitalization(3, 6 and 12 month)
- Procedure Time(intraoperatory)