Vital Pulp Therapy to Treat Irreversible Pulpitis

Overview

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.

Full Title of Study: “Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2008

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • ORCT
  • Experimental: 2
    • PCEM/PMTA

Clinical Trial Outcome Measures

Primary Measures

  • Clinical and radiographical success of pulpotomy with CEM cement
    • Time Frame: 5 year

Secondary Measures

  • Patient Assessment of Pain – Visual Analogue Scale
    • Time Frame: 7 day

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 9 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Saeed Asgary, Dean, Iranian Center foe Endodontic Research – Shahid Beheshti University of Medical Sciences
  • Overall Official(s)
    • Mohammad Jafar Eghbal, Prof., Study Director, Shahid Beheshti University of Medical Sciences
    • Jamileh Ghoddusi, Prof., Principal Investigator, Mashhad University of Medical Sciences

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