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

Universidad de Valparaiso

Status: Not yet enrolling

Conditions: Pulp Necroses; Periapical Diseases

Treatments: Procedure: Conventional Root Canal Treatment; Procedure: Autologous Regenerative Endodontic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05305417

211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 2 patient groups

Regenerative Endodontic Treatment

Experimental group

Description:

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.

Treatment:

Procedure: Autologous Regenerative Endodontic Treatment

Conventional root canal treatment

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Root Canal Treatment