We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00748280
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Saeed Asgary, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 8, 2008
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
Clinical and radiographical success of pulpotomy with CEM cement [ Time Frame: 5 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Non-inferiority of pulpotomy with MTA or a new endodontic filling material [ Time Frame: 24 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Patient Assessment of Pain - Visual Analogue Scale [ Time Frame: 7 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vital Pulp Therapy to Treat Irreversible Pulpitis
Official Title  ICMJE Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Pulpitis
Intervention  ICMJE
  • Procedure: One-visit root canal therapy
    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.
    Other Name: single-visit RCT
  • Procedure: pulpotomy
    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.
Study Arms  ICMJE
  • Experimental: 1
    ORCT
    Intervention: Procedure: One-visit root canal therapy
  • Experimental: 2
    PCEM/PMTA
    Intervention: Procedure: pulpotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2011)
615
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
600
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00748280
Other Study ID Numbers  ICMJE C/B/4/8253
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Saeed Asgary, Shahid Beheshti University of Medical Sciences
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohammad Jafar Eghbal, Prof. Shahid Beheshti University of Medical Sciences
Principal Investigator: Jamileh Ghoddusi, Prof. Mashhad University of Medical Sciences
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP