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

March 22, 2022 updated by: Universidad de Valparaiso

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regenerative Endodontic Treatment
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
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
Other Names:
  • Pulp revascularization
  • Pulp revitalization
  • Pulp regeneration
Active Comparator: Conventional root canal 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 inert biomaterial to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions
Other Names:
  • Endodontically-treated Teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth re-sensibilization
Time Frame: 3, 6 and 12 month
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
Time Frame: 3, 6 and 12 month
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
Time Frame: 3, 6 and 12 month
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
Time Frame: intraoperatory
total time required to perform each of the therapies recorded in minutes
intraoperatory

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Investigators

  • Study Director: Alicia Caro, MSC, DDS, Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.
  • Principal Investigator: Juan Caro, DDS, Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

from start of participants recruitment to 12 months after publication of results

IPD Sharing Access Criteria

The IPD data will be shared with any colleague or researcher that solicited the information by email to principal investigator explaining clear and direct the academic or research intention use of the data

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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