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Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)

Primary Purpose

Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
One-visit root canal therapy
pulpotomy
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulpitis focused on measuring Endodontics, CEM cement, Calcium enriched mixture, MTA, Root Canal Therapy, Pain, Pulpotomy, Human, Permanent, Molar teeth

Eligibility Criteria

9 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnostic criteria:

    1. Patient reports pain of endodontic origin
    2. Diagnosis of irreversible pulpitis
  • Eligibility criteria:

    1. Molar tooth
    2. Patient chooses to have tooth extraction for pain relief
    3. Age 9-65 years
    4. Both gender
    5. The patient had read and thoroughly understood the questionnaires; and
    6. Written informed consent
  • Exclusion Criteria:

    1. Moderate or severe periodontitis
    2. None restorable tooth
    3. Internal or external root resorption
    4. Root canal calcification
    5. No bleeding after access cavity preparation
    6. Analgesic taken within the last 4 h
    7. Active systemic disease
    8. The patient was pregnant or nursing
    9. History of opioid addiction or abuse
    10. Temporary residency

Sites / Locations

  • Iranian Center for Endodontic research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

ORCT

PCEM/PMTA

Outcomes

Primary Outcome Measures

Clinical and radiographical success of pulpotomy with CEM cement

Secondary Outcome Measures

Patient Assessment of Pain - Visual Analogue Scale

Full Information

First Posted
September 4, 2008
Last Updated
April 26, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00748280
Brief Title
Vital Pulp Therapy to Treat Irreversible Pulpitis
Acronym
VPT
Official Title
Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.
Detailed Description
In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit. In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
Keywords
Endodontics, CEM cement, Calcium enriched mixture, MTA, Root Canal Therapy, Pain, Pulpotomy, Human, Permanent, Molar teeth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
615 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ORCT
Arm Title
2
Arm Type
Experimental
Arm Description
PCEM/PMTA
Intervention Type
Procedure
Intervention Name(s)
One-visit root canal therapy
Other Intervention Name(s)
single-visit RCT
Intervention Description
Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.
Intervention Type
Procedure
Intervention Name(s)
pulpotomy
Intervention Description
Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.
Primary Outcome Measure Information:
Title
Clinical and radiographical success of pulpotomy with CEM cement
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Patient Assessment of Pain - Visual Analogue Scale
Time Frame
7 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnostic criteria: Patient reports pain of endodontic origin Diagnosis of irreversible pulpitis Eligibility criteria: Molar tooth Patient chooses to have tooth extraction for pain relief Age 9-65 years Both gender The patient had read and thoroughly understood the questionnaires; and Written informed consent Exclusion Criteria: Moderate or severe periodontitis None restorable tooth Internal or external root resorption Root canal calcification No bleeding after access cavity preparation Analgesic taken within the last 4 h Active systemic disease The patient was pregnant or nursing History of opioid addiction or abuse Temporary residency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jafar Eghbal, Prof.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jamileh Ghoddusi, Prof.
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iranian Center for Endodontic research
City
Tehran
ZIP/Postal Code
19839
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Vital Pulp Therapy to Treat Irreversible Pulpitis

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