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Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits

Primary Purpose

Irreversible Pulpitis, Mature Teeth

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulpotomy
Root Canal Therapy
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring pulpotomy, root canal therapy

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Intended to participate with this study, and provide informed assent/consent. Aged 18 and 59 years. At least one mature permanent teeth diagnosed as acute pulpitis or chronic pulpitis, and the teeth was in Nolla stage 9 and above by radiographic examination. To be prepared to appear for follow-up. Exclusion Criteria: Allergic to any medications or materials necessary to complete the procedures. The teeth with severe coronal defect that find to be non-restorable. The teeth with full crown restoration. The teeth with root fracture or vertical root fractures. Patients with periodontitis. Patients who are undergoing orthodontic treatment. 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 mental disorders. Patients with a history of systemic diseases that may alter immune function.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulpotomy

Root Canal Therapy

Arm Description

The removal of a small portion of the vital coronal pulp as a means of preserving the remaining coronal and radicular pulp tissues.

The complete removal of the vital dental pulp. Any material or combination of materials placed inside a root canal for the purpose of obturating and sealing the canal space.

Outcomes

Primary Outcome Measures

Success rate of pulpotomy and root canal therapy
The teeth were asymptomatic. Clinical examination showed absence of clinical signs of pain and abscess or sinus tract. Radiographic assessment showed absence of periapical radiolucency.

Secondary Outcome Measures

The pulp vitality in pulpotomy group
The pulpal vitality will be assessed through pulpal response to thermal and electric pulp tests in teeth treated with pulpotomy.
Survival rate of teeth
Survival rate of teeth will be evaluated by function and clinical symptoms.

Full Information

First Posted
November 13, 2022
Last Updated
November 13, 2022
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05622266
Brief Title
Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits
Official Title
Comparative Effectiveness of Pulpotomy and Root Canal Therapy in the Management of Mature Permanent Tooth With Irreversible Pulpits: a Randomized Controlled Non-inferiority Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang 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 pulpotomy in mature permanent tooth with irreversible pulpits, and compare the clinical efficacy of pulpotomy and root canal therapy.
Detailed Description
At present, root canal therapy ( RCT ) is still the main treatment for mature teeth diagnosed as irreversible pulpitis, but the teeth after RCT become non-vital, losing the immune defense mechanism and regeneration potential of pulp, which is not conducive to the long-term preservation of teeth. The traditional view is that mature permanent teeth with irreversible pulpitis are not indications for pulpotomy. However, with the deepening of pulp biology research and the availability of new pulp capping materials, the effect of pulpotomy is more predictable. Recent studies have shown that pulpotomy for irreversible pulpitis teeth can achieve good results, however, there is a lack of high-quality randomized controlled clinical studies, and the effect of pulpotomy compared with RCT studies rarely reported. Therefore, this project intends to explore the curative effect of pulpotomy on mature permanent teeth with irreversible pulpitis, and analyze the influence of age, tooth position and other factors on its curative effect, broaden the indications of pulpotomy, and establish the indications and standardized operation process of pulpotomy for mature permanent teeth with irreversible pulpitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis, Mature Teeth
Keywords
pulpotomy, root canal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulpotomy
Arm Type
Experimental
Arm Description
The removal of a small portion of the vital coronal pulp as a means of preserving the remaining coronal and radicular pulp tissues.
Arm Title
Root Canal Therapy
Arm Type
Active Comparator
Arm Description
The complete removal of the vital dental pulp. Any material or combination of materials placed inside a root canal for the purpose of obturating and sealing the canal space.
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy
Intervention Description
The patients who are randomly assigned to the experimental group receive pulpotomy.
Intervention Type
Procedure
Intervention Name(s)
Root Canal Therapy
Intervention Description
The patients who are randomly assigned to the Active Comparator group receive root canal therapy.
Primary Outcome Measure Information:
Title
Success rate of pulpotomy and root canal therapy
Description
The teeth were asymptomatic. Clinical examination showed absence of clinical signs of pain and abscess or sinus tract. Radiographic assessment showed absence of periapical radiolucency.
Time Frame
From baseline to two years
Secondary Outcome Measure Information:
Title
The pulp vitality in pulpotomy group
Description
The pulpal vitality will be assessed through pulpal response to thermal and electric pulp tests in teeth treated with pulpotomy.
Time Frame
From baseline to two years
Title
Survival rate of teeth
Description
Survival rate of teeth will be evaluated by function and clinical symptoms.
Time Frame
From baseline to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Intended to participate with this study, and provide informed assent/consent. Aged 18 and 59 years. At least one mature permanent teeth diagnosed as acute pulpitis or chronic pulpitis, and the teeth was in Nolla stage 9 and above by radiographic examination. To be prepared to appear for follow-up. Exclusion Criteria: Allergic to any medications or materials necessary to complete the procedures. The teeth with severe coronal defect that find to be non-restorable. The teeth with full crown restoration. The teeth with root fracture or vertical root fractures. Patients with periodontitis. Patients who are undergoing orthodontic treatment. 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 mental disorders. Patients with a history of systemic diseases that may alter immune function.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zilong Deng, Doctor
Phone
+86-020-62787149
Email
zldeng@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhigang Guo, Doctor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zilong Deng, Doctor
Phone
+86-020-62787149
Email
zldeng@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits

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