Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)

Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis
• Intervention / Treatment: Procedure: One-visit root canal therapy; Procedure: pulpotomy

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: Interventional
• Enrollment (Actual): 615
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19839
    • Iranian Center for Endodontic research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; ORCT	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 Names: single-visit RCT
Experimental: 2; PCEM/PMTA	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical and radiographical success of pulpotomy with CEM cement	5 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Assessment of Pain - Visual Analogue Scale	7 day

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Study Director: Mohammad Jafar Eghbal, Prof., Shahid Beheshti University of Medical Sciences; Principal Investigator: Jamileh Ghoddusi, Prof., Mashhad University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 4, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Pain; Human; Permanent; MTA; Endodontics; Pulpotomy; Root Canal Therapy; CEM cement; Calcium enriched mixture; Molar teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: C/B/4/8253