NCT04313010

Brief Summary

This study is to evaluate the effectiveness of regenerative endodontics therapy in single-rooted permanent teeth with pulp necrosis，and compare the clinical efficacy of platelet rich fibrin (PRF) and blood clot (BC) as scaffolds.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

4.3 years

First QC Date

March 16, 2020

Last Update Submit

March 19, 2020

Conditions

Pulp Necrosis

Keywords

Pulp NecrosisRegenerative Endodontics TherapyPlatelet Rich Fibrin

Outcome Measures

Primary Outcomes (1)

  • Success of regenerative endodontics therapy

    Success: Defined as symptoms, clinical and radiographic assessment of the teeth. The teeth with RET were asymptomatic; Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency.

    24 months

Secondary Outcomes (2)

  • Change in pulp vitality

    1、3、6、12、18、24 months

  • Adverse events

    1、3、6、12、18、24 months

Study Arms (2)

Regenerative endodontics therapy with PRF

EXPERIMENTAL

In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. Only the apex 1/3 of the root canal need to be filled with blood. PRF was injected into the root canal to a level below the CEJ, then wait for 10-15min to coagulate.

Other: PRF

Regenerative endodontics therapy with BC

ACTIVE COMPARATOR

In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. The adequate blood need to be full with canal space and below the CEJ, then wait for 10-15min to coagulate.

Other: BC

Interventions

PRFOTHER

A sample of whole venous blood was drawn from the patient's forearm. The blood sample was transferred into a tube without anticoagulant and centrifuged immediately using a centrifuge.

Regenerative endodontics therapy with PRF
BCOTHER

According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.

Regenerative endodontics therapy with BC

Eligibility Criteria

Age10 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Intended to participate with this study, and provide informed assent/consent.
  • Aged 10 and 59 years.
  • At least one mature permanent teeth diagnosed as pulp necrosis with or without periapical lesion, and CBCT showed the teeth has single root and single root canal.

You may not qualify if:

  • Allergic to any medications or materials necessary to complete the procedures.
  • The teeth with severe coronal defect, of which pulp space is needed for post/core final restoration.
  • Non-restorable teeth.
  • The teeth with root fracture or vertical root fractures.
  • Concurrent signs of other pathological root resorption.
  • Patients with periodontitis.
  • Patients with dental dysplasia or other oral genetic disorders.
  • Women who are pregnant or lactating, or women who plan to become pregnant in the subsequent 2 years.
  • Patients with dental phobia.
  • Patients with mental disorders.
  • Patients with a history of systemic diseases that may alter immune function.
  • Patients with medical conditions and/or receiving medications that would affect patients' body's ability of healing or blood clotting.
  • Participants who are participating in or had participated in other clinical studies within the prior 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nanfang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

Stomatological Hospital, Southern Medical University

Guangzhou, China

RECRUITING

Shenzhen Hospital, Southern Medical University

Shenzhen, China

RECRUITING

Related Publications (12)

  • Kim SG, Malek M, Sigurdsson A, Lin LM, Kahler B. Regenerative endodontics: a comprehensive review. Int Endod J. 2018 Dec;51(12):1367-1388. doi: 10.1111/iej.12954. Epub 2018 Jun 11.

    PMID: 29777616BACKGROUND

  • Diogenes A, Ruparel NB, Shiloah Y, Hargreaves KM. Regenerative endodontics: A way forward. J Am Dent Assoc. 2016 May;147(5):372-80. doi: 10.1016/j.adaj.2016.01.009. Epub 2016 Mar 24.

    PMID: 27017182BACKGROUND

  • Adnan S, Ullah R. Top-cited Articles in Regenerative Endodontics: A Bibliometric Analysis. J Endod. 2018 Nov;44(11):1650-1664. doi: 10.1016/j.joen.2018.07.015. Epub 2018 Sep 19.

    PMID: 30243658BACKGROUND

  • Saoud TM, Sigurdsson A, Rosenberg PA, Lin LM, Ricucci D. Treatment of a large cystlike inflammatory periapical lesion associated with mature necrotic teeth using regenerative endodontic therapy. J Endod. 2014 Dec;40(12):2081-6. doi: 10.1016/j.joen.2014.07.027. Epub 2014 Oct 5.

    PMID: 25292168BACKGROUND

  • Saoud TM, Martin G, Chen YH, Chen KL, Chen CA, Songtrakul K, Malek M, Sigurdsson A, Lin LM. Treatment of Mature Permanent Teeth with Necrotic Pulps and Apical Periodontitis Using Regenerative Endodontic Procedures: A Case Series. J Endod. 2016 Jan;42(1):57-65. doi: 10.1016/j.joen.2015.09.015. Epub 2015 Oct 31.

    PMID: 26525552BACKGROUND

  • Paryani K, Kim SG. Regenerative endodontic treatment of permanent teeth after completion of root development: a report of 2 cases. J Endod. 2013 Jul;39(7):929-34. doi: 10.1016/j.joen.2013.04.029. Epub 2013 May 14.

    PMID: 23791266BACKGROUND

  • Nageh M, Ahmed GM, El-Baz AA. Assessment of Regaining Pulp Sensibility in Mature Necrotic Teeth Using a Modified Revascularization Technique with Platelet-rich Fibrin: A Clinical Study. J Endod. 2018 Oct;44(10):1526-1533. doi: 10.1016/j.joen.2018.06.014. Epub 2018 Aug 31.

    PMID: 30174103BACKGROUND

  • Galler KM, Krastl G, Simon S, Van Gorp G, Meschi N, Vahedi B, Lambrechts P. European Society of Endodontology position statement: Revitalization procedures. Int Endod J. 2016 Aug;49(8):717-23. doi: 10.1111/iej.12629. Epub 2016 Apr 23.

    PMID: 26990236BACKGROUND

  • Ulusoy AT, Turedi I, Cimen M, Cehreli ZC. Evaluation of Blood Clot, Platelet-rich Plasma, Platelet-rich Fibrin, and Platelet Pellet as Scaffolds in Regenerative Endodontic Treatment: A Prospective Randomized Trial. J Endod. 2019 May;45(5):560-566. doi: 10.1016/j.joen.2019.02.002. Epub 2019 Mar 30.

    PMID: 30935618BACKGROUND

  • Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.

    PMID: 30003342BACKGROUND

  • Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.

    PMID: 28154995BACKGROUND

  • Liang Y, Ma R, Chen L, Dai X, Zuo S, Jiang W, Hu N, Deng Z, Zhao W. Efficacy of i-PRF in regenerative endodontics therapy for mature permanent teeth with pulp necrosis: study protocol for a multicentre randomised controlled trial. Trials. 2021 Jul 6;22(1):436. doi: 10.1186/s13063-021-05401-7.

    PMID: 34229752DERIVED

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wanghong Zhao, Doctor

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Central Study Contacts

Wanghong Zhao, Doctor

CONTACT

0086-020-62787680zhaowh@smu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

March 16, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

March 23, 2020

Record last verified: 2020-03

Locations

CN(3)