Clinical trial NCT00748280: Vital Pulp Therapy to Treat Irreversible Pulpitis
Official title: Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis
Keywords: Endodontics
CEM cement
Calcium enriched mixture
MTA
Root Canal Therapy
Pain
Pulpotomy
Human
Permanent
Molar teeth
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 615
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical and radiographical success of pulpotomy with CEM cement
timeFrame: 5 year
Secondary outcomes:
measure: Patient Assessment of Pain - Visual Analogue Scale
timeFrame: 7 day
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iranian Center for Endodontic research
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Jafar Eghbal, Prof.
role: STUDY_DIRECTOR
affiliation: Mashhad University of Medical Sciences
name: Jamileh Ghoddusi, Prof.
role: PRINCIPAL_INVESTIGATOR
References: