Overview

This trial is active, not recruiting.

Condition pulpitis
Treatments one-visit root canal therapy, pulpotomy
Phase phase 3
Sponsor Shahid Beheshti Medical University
Start date April 2008
End date September 2008
Trial size 615 participants
Trial identifier NCT00748280, C/B/4/8253

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
ORCT
one-visit root canal therapy single-visit RCT
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.
(Experimental)
PCEM/PMTA
pulpotomy 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.

Primary Outcomes

Measure
Clinical and radiographical success of pulpotomy with CEM cement
time frame: 5 year

Secondary Outcomes

Measure
Patient Assessment of Pain - Visual Analogue Scale
time frame: 7 day

Eligibility Criteria

Male or female participants from 9 years up to 65 years old.

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

Additional Information

Official title Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
Principal investigator Jamileh Ghoddusi, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Shahid Beheshti Medical University.