Vital Pulp Therapy to Treat Irreversible Pulpitis - Full Text View

Sponsors and Collaborators:	Shaheed Beheshti Medical University Office for Oral Health - Ministry of Health and Medical Education
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00748280

Purpose

The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with mineral trioxide aggregate or new endodontic cement) as a new treatment with 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 with mineral trioxide aggregate Procedure: pulpotomy with new endodontic cement	Phase III

MedlinePlus related topics: Minerals

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment
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 MTA or a new endodontic cement [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: One-visit root canal therapy
2: Experimental	Procedure: Pulpotomy with mineral trioxide aggregate
3: Experimental	Procedure: pulpotomy with new endodontic cement

Detailed Description:

In one visit RCT (Arm 1): The teeth were anaesthetized, 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 radiographs. Sterile normal saline solution was used for intracanal 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 mineral trioxide aggregate (Arm 2) or new endodontic cement (Arm 3): The teeth were anaesthetized. 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 or NEC. Cements 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

Office for Oral Health - Ministry of Health and Medical Education

Investigators

Study Director:	Mohammad Jafar Eghbal, Prof.	Shaheed Beheshti Medical University
Principal Investigator:	Jamileh Ghoddusi, Prof.	Mashad Medical University,
Principal Investigator:	Masoud Parirokh, Prof.	Kerman Medical University

More Information

Study ID Numbers:	C/B/4/8253
Study First Received:	September 4, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00748280
Health Authority:	Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:

Endodontics
new material
mineral trioxide aggregate
Root Canal Therapy
Clinic Visits

Study placed in the following topic categories:

Tooth Diseases
Dental Pulp Diseases
Stomatognathic Diseases
Pulpitis

ClinicalTrials.gov processed this record on January 14, 2009