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Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis

Primary Purpose

Pulp Necrosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PRF
BC
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring Pulp Necrosis, Regenerative Endodontics Therapy, Platelet Rich Fibrin

Eligibility Criteria

10 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting
  • Stomatological Hospital, Southern Medical UniversityRecruiting
  • Shenzhen Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regenerative endodontics therapy with PRF

Regenerative endodontics therapy with BC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in pulp vitality
Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in teeth treated with RET.
Adverse events
Such as discoloration, reinfection, root resorption and so on.

Full Information

First Posted
March 16, 2020
Last Updated
March 19, 2020
Sponsor
Southern Medical University, China
Collaborators
Stomatological Hospital, Southern Medical University, Shenzhen Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04313010
Brief Title
Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis
Official Title
Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis: a Multicenter Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2020 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Medical University, China
Collaborators
Stomatological Hospital, Southern Medical University, Shenzhen Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Regenerative endodontics therapy (RET), based on the principles of tissue engineering, manipulates stem cells, scaffold, and bioactive growth factors to achieve the functional reconstruction of pulp tissue. RET has been recommended strongly as an alternative in treating immature permanent teeth with necrotic pulp in recent years, while root canal therapy (RCT) has been extensively applied in the treatment of mature permanent teeth with necrotic pulp. RCT contains the chemomechanical preparation of the infected root canals to eliminate the microorganisms, and root canal obturation with filling materials to reduce and prevent microbial contamination in root canal system. However, the root canal filling materials, such as Gutta-percha, are inert materials which fail to recover the physiological function of the pulp. As RET has been proved curative for immature permanent teeth diagnosed with pulp necrosis, doctors and researchers try to extend its application in the mature ones. Encouragingly, several RET cases for mature teeth reported in the literature have shown positive clinical outcomes. However, it still lacks long-term and well-designed randomized clinical trial with large sample size and following standardized protocol, hence this study is conducted to make up for it to achieve high-level evidence. In the process of RET, the scaffold can provide nutrition and space, which are essential for the proliferation and differentiation of stem cells. Therefore, it is a crucial step to select a high-quality material as the scaffold. In many studies of RET procedures, blood clot (BC), generated by provoking apical bleeding into the root canal, is regarded as a scaffold. Nevertheless, it remains a common problem that operators may fail to induce apical bleeding or achieve adequate blood volume. Recent studies suggest that patelet rich fibrin (PRF), the second-generation platelet concentrate, can provide a fibrin network full of cytokines and growth factors, which may improve the desired biological outcome. Accordingly, we assumed that PRF could improve the curative effect for mature teeth in RET. The purpose of this study is to compare the clinical efficacy of PRF and BC as scaffolds in RET for the mature permanent tooth with pulp necrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necrosis
Keywords
Pulp Necrosis, Regenerative Endodontics Therapy, Platelet Rich Fibrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regenerative endodontics therapy with PRF
Arm Type
Experimental
Arm Description
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.
Arm Title
Regenerative endodontics therapy with BC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PRF
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
BC
Intervention Description
According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.
Primary Outcome Measure Information:
Title
Success of regenerative endodontics therapy
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in pulp vitality
Description
Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in teeth treated with RET.
Time Frame
1、3、6、12、18、24 months
Title
Adverse events
Description
Such as discoloration, reinfection, root resorption and so on.
Time Frame
1、3、6、12、18、24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanghong Zhao, Doctor
Phone
0086-020-62787680
Email
zhaowh@smu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanghong Zhao, Doctor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanghong Zhao, Doctor
Phone
0086-020-62787680
Email
zhaowh@smu.edu.cn
Facility Name
Stomatological Hospital, Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wen, Doctor
Email
drwenjun@sina.com
Facility Name
Shenzhen Hospital, Southern Medical University
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Sui, Doctor
Email
wens27@163.com

12. IPD Sharing Statement

Citations:
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29777616
Citation
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Citation
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Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis

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