An interventional study of Autologous Regenerative Endodontic Treatment and Conventional Root Canal Treatment in Periapical Diseases and Pulp Necroses, sponsored by Universidad de Valparaiso. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Universidad de Valparaiso · Not applicable, Interventional, and Treatment
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.
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.
149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.
This study's planned enrollment of 228 is above the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Universidad de Valparaiso is the lead sponsor of 28 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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
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
Also known as: Pulp revascularization, Pulp revitalization, Pulp regeneration
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
Also known as: Endodontically-treated Teeth
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.
Time frame: 12 month
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.
Time frame: 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.
Time frame: 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
Time frame: 3, 6 and 12 month
Procedure Time
total time required to perform each of the therapies recorded in minutes
Time frame: intraoperatory
No study locations are listed for this record.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Icf
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Universidad de Valparaiso