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

NCT05305417 | Unknown DMC

• 1 other identifier: 211
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periapical Diseases; Pulp Necroses

Keywords

Regenerative Endodontics; Permanent Dentition; Pulp Necroses; Periapical Diseases; Root Canal Filling Material

Outcome Measures

Primary Outcomes (1)

• 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.

  12 month

Secondary Outcomes (4)

• Tooth re-sensibilization

  3, 6 and 12 month

• Tooth re-vitalization

  3, 6 and 12 month

• Periapical lesion resolution

  3, 6 and 12 month

• Procedure Time

  intraoperatory

Study Arms (2)

Regenerative Endodontic Treatment

EXPERIMENTAL

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

Conventional root canal treatment

ACTIVE COMPARATOR

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

Interventions

Autologous Regenerative Endodontic Treatment PROCEDURE

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

Regenerative Endodontic Treatment

Conventional Root Canal Treatment PROCEDURE

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

Conventional root canal treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Valparaiso: lead

Related Publications (21)

• Glynis A, Foschi F, Kefalou I, Koletsi D, Tzanetakis GN. Regenerative Endodontic Procedures for the Treatment of Necrotic Mature Teeth with Apical Periodontitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2021 Jun;47(6):873-882. doi: 10.1016/j.joen.2021.03.015. Epub 2021 Mar 31.

  PMID: 33811981 BACKGROUND

• Marquis VL, Dao T, Farzaneh M, Abitbol S, Friedman S. Treatment outcome in endodontics: the Toronto Study. Phase III: initial treatment. J Endod. 2006 Apr;32(4):299-306. doi: 10.1016/j.joen.2005.10.050.

  PMID: 16554199 BACKGROUND

• Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001.

  PMID: 14686806 BACKGROUND

• Farzaneh M, Abitbol S, Lawrence HP, Friedman S; Toronto Study. Treatment outcome in endodontics-the Toronto Study. Phase II: initial treatment. J Endod. 2004 May;30(5):302-9. doi: 10.1097/00004770-200405000-00002.

  PMID: 15107640 BACKGROUND

• Moazami F, Sahebi S, Sobhnamayan F, Alipour A. Success rate of nonsurgical endodontic treatment of nonvital teeth with variable periradicular lesions. Iran Endod J. 2011 Summer;6(3):119-24. Epub 2011 Aug 15.

  PMID: 23130063 BACKGROUND

• Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.

  PMID: 22892729 BACKGROUND

• Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.

  PMID: 17931388 BACKGROUND

• Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.

  PMID: 17931389 BACKGROUND

• Diogenes A, Ruparel NB. Regenerative Endodontic Procedures: Clinical Outcomes. Dent Clin North Am. 2017 Jan;61(1):111-125. doi: 10.1016/j.cden.2016.08.004.

  PMID: 27912813 BACKGROUND

• Widbiller M, Eidt A, Lindner SR, Hiller KA, Schweikl H, Buchalla W, Galler KM. Dentine matrix proteins: isolation and effects on human pulp cells. Int Endod J. 2018 May;51 Suppl 4:e278-e290. doi: 10.1111/iej.12754. Epub 2017 Mar 14.

  PMID: 28211068 BACKGROUND

• Galler KM, Buchalla W, Hiller KA, Federlin M, Eidt A, Schiefersteiner M, Schmalz G. Influence of root canal disinfectants on growth factor release from dentin. J Endod. 2015 Mar;41(3):363-8. doi: 10.1016/j.joen.2014.11.021. Epub 2015 Jan 13.

  PMID: 25595468 BACKGROUND

• Galler KM, D'Souza RN, Federlin M, Cavender AC, Hartgerink JD, Hecker S, Schmalz G. Dentin conditioning codetermines cell fate in regenerative endodontics. J Endod. 2011 Nov;37(11):1536-41. doi: 10.1016/j.joen.2011.08.027.

  PMID: 22000458 BACKGROUND

• Smith AJ, Scheven BA, Takahashi Y, Ferracane JL, Shelton RM, Cooper PR. Dentine as a bioactive extracellular matrix. Arch Oral Biol. 2012 Feb;57(2):109-21. doi: 10.1016/j.archoralbio.2011.07.008.

  PMID: 21855856 BACKGROUND

• Galler KM. Clinical procedures for revitalization: current knowledge and considerations. Int Endod J. 2016 Oct;49(10):926-36. doi: 10.1111/iej.12606. Epub 2016 Feb 1.

  PMID: 26715631 BACKGROUND

• Ducret M, Fabre H, Celle A, Mallein-Gerin F, Perrier-Groult E, Alliot-Licht B, Farges JC. Current challenges in human tooth revitalization. Biomed Mater Eng. 2017;28(s1):S159-S168. doi: 10.3233/BME-171637.

  PMID: 28372291 BACKGROUND

• Chrepa V, Henry MA, Daniel BJ, Diogenes A. Delivery of Apical Mesenchymal Stem Cells into Root Canals of Mature Teeth. J Dent Res. 2015 Dec;94(12):1653-9. doi: 10.1177/0022034515596527. Epub 2015 Jul 20.

  PMID: 26195498 BACKGROUND

• Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.

  PMID: 31155298 BACKGROUND

• Jha P, Virdi MS, Nain S. A Regenerative Approach for Root Canal Treatment of Mature Permanent Teeth: Comparative Evaluation with 18 Months Follow-up. Int J Clin Pediatr Dent. 2019 May-Jun;12(3):182-188. doi: 10.5005/jp-journals-10005-1616.

  PMID: 31708612 BACKGROUND

• Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.

  PMID: 32202965 BACKGROUND

• About I. Proceedings of the Pulp Biology and Regeneration Group Symposium 2019: Bridging Basic and Translational Research in Pulp Biology-Developing Technologies for Regenerating Vital Dental Tissues. J Endod. 2020 Sep;46(9S):S1. doi: 10.1016/j.joen.2020.06.018. No abstract available.

  PMID: 32950179 BACKGROUND

• He L, Kim SG, Gong Q, Zhong J, Wang S, Zhou X, Ye L, Ling J, Mao JJ. Regenerative Endodontics for Adult Patients. J Endod. 2017 Sep;43(9S):S57-S64. doi: 10.1016/j.joen.2017.06.012.

  PMID: 28844305 BACKGROUND

MeSH Terms

Conditions

Periapical Diseases; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alicia Caro, MSC, DDS

  Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.

  STUDY DIRECTOR

• Juan Caro, DDS

  Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Caro, DDS

CONTACT

+56975242484; juancarlos.caro@uv.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants don´t know wich intervention receive Investigator (outcome evaluator) don´t know wich intervention evaluate Outcomes Assessor (statistics) don´t know wich arm data evaluate
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: from start of participants recruitment to 12 months after publication of results
• 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