VPT: Vital Pulp Therapy to Treat Irreversible Pulpitis

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00748280

Collaborator

(none)

615

Enrollment

Location

Arms

101

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulpitis	Procedure: One-visit root canal therapy Procedure: pulpotomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

615 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Clinical and radiographical success of pulpotomy with CEM cement [5 year]

Secondary Outcome Measures

Patient Assessment of Pain - Visual Analogue Scale [7 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnostic criteria:

Patient reports pain of endodontic origin
Diagnosis of irreversible pulpitis

Eligibility criteria:

Molar tooth
Patient chooses to have tooth extraction for pain relief
Age 9-65 years
Both gender
The patient had read and thoroughly understood the questionnaires; and
Written informed consent

Exclusion Criteria:

Moderate or severe periodontitis
None restorable tooth
Internal or external root resorption
Root canal calcification
No bleeding after access cavity preparation
Analgesic taken within the last 4 h
Active systemic disease
The patient was pregnant or nursing
History of opioid addiction or abuse
Temporary residency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iranian Center for Endodontic research	Tehran		Iran, Islamic Republic of	19839

Sponsors and Collaborators

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