Vital Pulp Therapy to Treat Irreversible Pulpitis

NCT ID: NCT00748280

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 615 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2016-09-30

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.

Conditions

Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1

ORCT

Group Type: EXPERIMENTAL

One-visit root canal therapy

Intervention Type: PROCEDURE

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.

2

PCEM/PMTA

Group Type: EXPERIMENTAL

pulpotomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

single-visit RCT

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Saeed Asgary

Dean, Iranian Center foe Endodontic Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad Jafar Eghbal, Prof.

Role: STUDY_DIRECTOR

Shahid Beheshti University of Medical Sciences

Jamileh Ghoddusi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Mashhad University of Medical Sciences

Locations

Iranian Center for Endodontic research

Tehran, , Iran

Countries

Iran

Other Identifiers

C/B/4/8253

Identifier Type: -

Identifier Source: org_study_id