Vital Pulp Therapy to Treat Irreversible Pulpitis - Full Text View

Purpose

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	Intervention	Phase
Pulpitis	Procedure: One-visit root canal therapy Procedure: pulpotomy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Clinical and radiographical success of pulpotomy with CEM cement [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Patient Assessment of Pain - Visual Analogue Scale [ Time Frame: 7 day ] [ Designated as safety issue: Yes ]

Enrollment:	615
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2013
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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. Other Name: pulpotomy

Arms

Assigned Interventions

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 Name: 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.

Other Name: 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.

Eligibility

Ages Eligible for Study:	9 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748280

Locations

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

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Study Director:	Mohammad Jafar Eghbal, Prof.	Shaheed Beheshti Medical University
Principal Investigator:	Jamileh Ghoddusi, Prof.	Mashhad University of Medical Sciences

More Information

No publications provided

Responsible Party:	Saeed Asgary/ Dean, Iranian Center for Endodontic Research
ClinicalTrials.gov Identifier:	NCT00748280 History of Changes
Other Study ID Numbers:	C/B/4/8253
Study First Received:	September 4, 2008
Last Updated:	June 22, 2011
Health Authority:	Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:

Endodontics
CEM cement
Calcium enriched mixture
MTA
Root Canal Therapy

Pain
Pulpotomy
Human
Permanent
Molar teeth

Additional relevant MeSH terms:

Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)